Vicair Active O2



Vicair Active O2 is suitable for the active user and in need of pressure relief at the back.
Active O2 has a stable foam edge at the front, which provides support for the thighs and facilitates transfers to and from the wheelchair.
Active O2 is delivered ready to use incl. breathable cover.
Cover and air cells can be washed at 60 degrees celcius.

Classification
04 33 03 03 - Air cushions for pressure-sore prevention, static



The product series contains 34 products.

Product 1 of 34
Vicair Active O2 350x400


HMI-no.
108714
Article-no.
OCT9/3540

Registration date
09-03-2018
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
35
cm
Depth
40
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 2 of 34
Vicair Active O2 400x400


HMI-no.
108715
Article-no.
OCT9/4040

Registration date
09-03-2018
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
40
cm
Depth
40
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 3 of 34
Vicair Active O2 400x450


HMI-no.
108716
Article-no.
OCT9/4045

Registration date
09-03-2018
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
40
cm
Depth
45
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 4 of 34
Vicair Active O2 400x500


HMI-no.
108717
Article-no.
OCT9/4050

Registration date
09-03-2018
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
40
cm
Depth
50
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 5 of 34
Vicair Active O2 450x400


HMI-no.
108718
Article-no.
OCT9/4540

Registration date
09-03-2018
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
45
cm
Depth
40
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 6 of 34
Vicair Active O2 450x450


HMI-no.
108719
Article-no.
OCT9/4545

Registration date
09-03-2018
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
45
cm
Depth
45
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 7 of 34
Vicair Active O2 450x500


HMI-no.
108720
Article-no.
OCT9/4550

Registration date
09-03-2018
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
45
cm
Depth
50
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 8 of 34
Vicair Active O2 500x450


HMI-no.
108721
Article-no.
OCT9/5045

Registration date
09-03-2018
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
50
cm
Depth
45
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 9 of 34
Vicair Active O2 500x500


HMI-no.
108722
Article-no.
OCT9/5050

Registration date
09-03-2018
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
50
cm
Depth
50
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device

Product 10 of 34
Vicair Active O2 6cm 350x400


HMI-no.
140623
Article-no.
OCT6/3540

Registration date
15-06-2024
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
35
cm
Depth
40
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 140623

Product 11 of 34
Vicair Active O2 6cm 350x450


HMI-no.
137567
Article-no.
OCT9/3545

Registration date
02-08-2023
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
35
cm
Depth
45
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 137567

Product 12 of 34
Vicair Active O2 6cm 400x400


HMI-no.
140624
Article-no.
OCT6/4040

Registration date
15-06-2024
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
40
cm
Depth
40
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 140624

Product 13 of 34
Vicair Active O2 6cm 400x450


HMI-no.
140626
Article-no.
OCT6/4045

Registration date
15-06-2024
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
40
cm
Depth
45
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 140626

Product 14 of 34
Vicair Active O2 6cm 430x430


HMI-no.
140625
Article-no.
OCT6/4343

Registration date
15-06-2024
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
43
cm
Depth
43
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 140625

Product 15 of 34
Vicair Active O2 6cm 450x500


HMI-no.
140627
Article-no.
OCT6/4550

Registration date
15-06-2024
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
45
cm
Depth
50
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 140627

Product 16 of 34
Vicair Active O2, 35 x 35 x 10 cm, incl. Aero cover


HMI-no.
147333
Article-no.
OAC9/AX/3535

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
35
cm
Depth
35
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147333

Product 17 of 34
Vicair Active O2, 35 x 40 x 6 cm, incl. Aero cover


HMI-no.
147342
Article-no.
OAC6/AX/3540

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
35
cm
Depth
40
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147342

Product 18 of 34
Vicair Active O2, 35 x 45 x 10 cm, incl. Aero cover


HMI-no.
147331
Article-no.
OAC9/AX/3545

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
35
cm
Depth
45
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147331

Product 19 of 34
Vicair Active O2, 40 x 40 x 10 cm, incl. Aero cover


HMI-no.
147332
Article-no.
OAC9/AX/4040

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
40
cm
Depth
40
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147332

Product 20 of 34
Vicair Active O2, 40 x 40 x 6 cm, incl. Aero cover


HMI-no.
147343
Article-no.
OAC6/AX/4040

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
40
cm
Depth
40
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147343

Product 21 of 34
Vicair Active O2, 40 x 45 x 10 cm, incl. Aero cover


HMI-no.
147334
Article-no.
OAC9/AX/4045

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
40
cm
Depth
45
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147334

Product 22 of 34
Vicair Active O2, 40 x 45 x 6 cm, incl. Aero cover


HMI-no.
147344
Article-no.
OAC6/AX/4045

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
40
cm
Depth
45
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147344

Product 23 of 34
Vicair Active O2, 40 x 50 x 10 cm, incl. Aero cover


HMI-no.
147335
Article-no.
OAC9/AX/4050

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
40
cm
Depth
50
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147335

Product 24 of 34
Vicair Active O2, 43 x 43 x 6 cm, incl. Aero cover


HMI-no.
147345
Article-no.
OAC6/AX/4343

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
43
cm
Depth
43
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147345

Product 25 of 34
Vicair Active O2, 45 x 40 x 10 cm, incl. Aero cover


HMI-no.
147336
Article-no.
OAC9/AX/4540

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
45
cm
Depth
50
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147336

Product 26 of 34
Vicair Active O2, 45 x 40 x 6 cm, incl. Aero cover


HMI-no.
147346
Article-no.
OAC6/AX/4540

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
45
cm
Depth
40
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147346

Product 27 of 34
Vicair Active O2, 45 x 45 x 10 cm, incl. Aero cover


HMI-no.
147337
Article-no.
OAC9/AX/4545

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
45
cm
Depth
40
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147337

Product 28 of 34
Vicair Active O2, 45 x 50 x 10 cm, inkl. Aero betræk


HMI-no.
147338
Article-no.
OAC9/AX/4550

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
45
cm
Depth
50
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147338

Product 29 of 34
Vicair Active O2, 45 x 50 x 6 cm, incl. Aero cover


HMI-no.
147347
Article-no.
OAC6/AX/4550

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
45
cm
Depth
50
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147347

Product 30 of 34
Vicair Active O2, 50 x 40 x 10 cm, incl. Aero cover


HMI-no.
147339
Article-no.
OAC9/AX/5040

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
50
cm
Depth
40
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147339

Product 31 of 34
Vicair Active O2, 50 x 45 x 10 cm, incl. Aero cover


HMI-no.
147340
Article-no.
OAC9/AX/5045

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
50
cm
Depth
45
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147340

Product 32 of 34
Vicair Active O2, 50 x 45 x 6 cm, incl. Aero cover


HMI-no.
147348
Article-no.
OAC6/AX/5045

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
50
cm
Depth
45
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147348

Product 33 of 34
Vicair Active O2, 50 x 50 x 10 cm, incl. Aero cover


HMI-no.
147341
Article-no.
OAC9/AX/5050

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
50
cm
Depth
50
cm
Corresponding to the seat depth of the chair
Height
10
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147341

Product 34 of 34
Vicair Active O2, 50 x 50 x 6 cm, inkl. Aero betræk


HMI-no.
147349
Article-no.
OAC6/AX/5050

Registration date
09-02-2026
Last updated
10-03-2026

Properties
Can be adjusted asymmetrically
Yes
The cushion as a whole is machine washable
Yes

Measures
Width
50
cm
Depth
50
cm
Corresponding to the seat depth of the chair
Height
6
cm
User weight, max
200
kg

Test information
No information about tests according to standards
The supplier has not provided documentation, that this product is testet according to a relevant standard. See examples of relevant standards for this product type

EU product safety regulation 
The supplier has provided the following information about CE-marking of the product. Explain CE-marking
CE marked as medical device
EU declaration of conformity for HMI-no. 147349