ProFem Gellhorn Pessary


Classification
09 31 03 01 - Vaginal devices for compression of the urethra

Documents


The product series contains 20 products.

Product 1 of 20
ProFem Gellhorn Short size 0 - 38 mm


HMI-no.
146392
Article-no.
G1.50-0

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146392

Product 2 of 20
ProFem Gellhorn Short size 1 - 45 mm


HMI-no.
146395
Article-no.
G1.75-1

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146395

Product 3 of 20
ProFem Gellhorn Short size 2 - 51 mm


HMI-no.
146398
Article-no.
G2.00-2

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146398

Product 4 of 20
ProFem Gellhorn Short size 3 - 57 mm


HMI-no.
146401
Article-no.
G2.25-3

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146401

Product 5 of 20
ProFem Gellhorn Short size 4 - 63 mm


HMI-no.
146404
Article-no.
G2.50-4

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146404

Product 6 of 20
ProFem Gellhorn Short size 5 - 70 mm


HMI-no.
146407
Article-no.
G2.75-5

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146407

Product 7 of 20
ProFem Gellhorn Short size 6 - 76 mm


HMI-no.
146410
Article-no.
G3.00-6

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146410

Product 8 of 20
ProFem Gellhorn Short size 7 - 82 mm


HMI-no.
146413
Article-no.
G3.25-7

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146413

Product 9 of 20
ProFem Gellhorn Short size 8 - 89 mm


HMI-no.
146416
Article-no.
G3.50-8

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146416

Product 10 of 20
ProFem Gellhorn Short size 9 - 95 mm


HMI-no.
146419
Article-no.
G3.75-9

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146419

Product 11 of 20
ProFem Gellhorn size 0 - 38 mm


HMI-no.
146362
Article-no.
G1.50D-0

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146362

Product 12 of 20
ProFem Gellhorn size 1 - 45 mm


HMI-no.
146365
Article-no.
G1.75D-1

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146365

Product 13 of 20
ProFem Gellhorn size 2 - 51 mm


HMI-no.
146368
Article-no.
G2.00D-2

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146368

Product 14 of 20
ProFem Gellhorn size 3 - 57 mm


HMI-no.
146371
Article-no.
G2.25D-3

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146371

Product 15 of 20
ProFem Gellhorn size 4 - 63 mm


HMI-no.
146374
Article-no.
G2.50D-4

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146374

Product 16 of 20
ProFem Gellhorn size 5 - 70 mm


HMI-no.
146377
Article-no.
G2.75D-5

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146377

Product 17 of 20
ProFem Gellhorn size 6 - 76 mm


HMI-no.
146380
Article-no.
G3.00D-6

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146380

Product 18 of 20
ProFem Gellhorn size 7 - 82 mm


HMI-no.
146383
Article-no.
G3.25D-7

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146383

Product 19 of 20
ProFem Gellhorn size 8 - 89 mm


HMI-no.
146386
Article-no.
G3.50D-8

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146386

Product 20 of 20
ProFem Gellhorn size 9 - 95 mm


HMI-no.
146389
Article-no.
G3.75D-9

Registration date
07-11-2025
Last updated
10-11-2025

Properties
Material
Silikone

Measures
Recommended usage time
24
timer

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. 146389