ProFem Donut Pessary


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

Documents


The product series contains 7 products.

Product 1 of 7
ProFem Donut Pessary size 0 - 50 mm


HMI-no.
146420
Article-no.
D2.00-0

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. 146420

Product 2 of 7
ProFem Donut Pessary size 1 - 58 mm


HMI-no.
146423
Article-no.
D2.25-1

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. 146423

Product 3 of 7
ProFem Donut Pessary size 2 - 64 mm


HMI-no.
146426
Article-no.
D2.50-2

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. 146426

Product 4 of 7
ProFem Donut Pessary size 3 - 70 mm


HMI-no.
146429
Article-no.
D2.75-3

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. 146429

Product 5 of 7
ProFem Donut Pessary size 4 - 76 mm


HMI-no.
146432
Article-no.
D3.00-4

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. 146432

Product 6 of 7
ProFem Donut Pessary size 5 - 83 mm


HMI-no.
146435
Article-no.
D3.25-5

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. 146435

Product 7 of 7
ProFem Donut Pessary size 6 - 88 mm


HMI-no.
146438
Article-no.
D3.50-6

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. 146438