Abena Nova Form, with sensor


Classification
09 30 21 04 - Single-use diapers for adults, extra heavy urinary incontinence




The product series contains 6 products.

Product 1 of 6
Abena Nova Form, L2, white, with sensor


HMI-no.
130716
Article-no.
1000016645

Registration date
21-10-2021
Last updated
21-11-2023

Properties
Belt fixation system
No
Wetness indicator
No
Specially designed for men
No
Specially designed for women
No
Unisex
Yes
Especially designed to collect faecal material
Yes

Measures
Absorption capacity (ISO 11948-1 (Rothwell))
3100
ml
Absorption capacity when submerged into water. Absorbtion capacity in use is less.
Hip circumference, min
100
cm
Hip circumference of user
Hip circumference, max
150
cm

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 6
Abena Nova Form, M2, white, with sensor


HMI-no.
130714
Article-no.
1000016643

Registration date
20-10-2021
Last updated
21-11-2023

Properties
Belt fixation system
No
Wetness indicator
No
Specially designed for men
No
Specially designed for women
No
Unisex
Yes
Especially designed to collect faecal material
Yes

Measures
Absorption capacity (ISO 11948-1 (Rothwell))
2600
ml
Absorption capacity when submerged into water. Absorbtion capacity in use is less.
Hip circumference, min
70
cm
Hip circumference of user
Hip circumference, max
110
cm

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 6
Abena Nova Form, M4, white, with sensor


HMI-no.
130715
Article-no.
1000016644

Registration date
21-10-2021
Last updated
21-11-2023

Properties
Belt fixation system
No
Wetness indicator
No
Specially designed for men
No
Specially designed for women
No
Unisex
Yes
Especially designed to collect faecal material
Yes

Measures
Absorption capacity (ISO 11948-1 (Rothwell))
3600
ml
Absorption capacity when submerged into water. Absorbtion capacity in use is less.
Hip circumference, min
70
cm
Hip circumference of user
Hip circumference, max
110
cm

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 6
Abena Nova Form, XL2, 970x850mm, white, with sensor


HMI-no.
130718
Article-no.
1000018942

Registration date
21-10-2021
Last updated
21-11-2023

Properties
Belt fixation system
No
Wetness indicator
No
Specially designed for men
No
Specially designed for women
No
Unisex
Yes
Especially designed to collect faecal material
Yes

Measures
Absorption capacity (ISO 11948-1 (Rothwell))
3400
ml
Absorption capacity when submerged into water. Absorbtion capacity in use is less.
Hip circumference, min
110
cm
Hip circumference of user
Hip circumference, max
170
cm

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 6
Abena Nova Form, XL4, 970x850mm, white, with sensor


HMI-no.
130719
Article-no.
1000018943

Registration date
21-10-2021
Last updated
21-11-2023

Properties
Belt fixation system
No
Wetness indicator
No
Specially designed for men
No
Specially designed for women
No
Unisex
Yes
Especially designed to collect faecal material
Yes

Measures
Absorption capacity (ISO 11948-1 (Rothwell))
4000
ml
Absorption capacity when submerged into water. Absorbtion capacity in use is less.
Hip circumference, min
110
cm
Hip circumference of user
Hip circumference, max
170
cm

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 6
Tapeble, Abena Nova Form, L4, white, with sensor


HMI-no.
130717
Article-no.
1000016646

Registration date
21-10-2021
Last updated
21-11-2023

Properties
Belt fixation system
No
Wetness indicator
No
Specially designed for men
No
Specially designed for women
No
Unisex
Yes
Especially designed to collect faecal material
Yes

Measures
Absorption capacity (ISO 11948-1 (Rothwell))
4000
ml
Absorption capacity when submerged into water. Absorbtion capacity in use is less.
Hip circumference, min
100
cm
Hip circumference of user
Hip circumference, max
150
cm

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