ProFem Urethra Shell Pessary


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

Documents


The product series contains 16 products.

Product 1 of 16
ProFem Urethra Pessary, size 0


HMI-no.
145276
Article-no.
DSH50-0

Registration date
01-07-2025
Last updated
08-10-2025

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. 145276

Product 2 of 16
ProFem Urethra Shell Pessary with reinforcement, size 0


HMI-no.
145303
Article-no.
DSH50S-0

Registration date
01-07-2025
Last updated
08-10-2025

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. 145303

Product 3 of 16
ProFem Urethra Shell Pessary with reinforcement, size 1


HMI-no.
145306
Article-no.
DSH55S-1

Registration date
01-07-2025
Last updated
08-10-2025

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. 145306

Product 4 of 16
ProFem Urethra Shell Pessary with reinforcement, size 2


HMI-no.
145309
Article-no.
DSH60S-2

Registration date
01-07-2025
Last updated
08-10-2025

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. 145309

Product 5 of 16
ProFem Urethra Shell Pessary with reinforcement, size 3


HMI-no.
145312
Article-no.
DSH65S-3

Registration date
01-07-2025
Last updated
08-10-2025

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. 145312

Product 6 of 16
ProFem Urethra Shell Pessary with reinforcement, size 4


HMI-no.
145315
Article-no.
DSH70S-4

Registration date
01-07-2025
Last updated
08-10-2025

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. 145315

Product 7 of 16
ProFem Urethra Shell Pessary with reinforcement, size 5


HMI-no.
145318
Article-no.
DSH75S-5

Registration date
01-07-2025
Last updated
08-10-2025

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. 145318

Product 8 of 16
ProFem Urethra Shell Pessary with reinforcement, size 6


HMI-no.
145321
Article-no.
DSH80S-6

Registration date
01-07-2025
Last updated
08-10-2025

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. 145321

Product 9 of 16
ProFem Urethra Shell Pessary with reinforcement, size 7


HMI-no.
145324
Article-no.
DSH85S-7

Registration date
01-07-2025
Last updated
08-10-2025

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. 145324

Product 10 of 16
ProFem Urethra Shell Pessary, size 1


HMI-no.
145279
Article-no.
DSH55-1

Registration date
01-07-2025
Last updated
08-10-2025

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. 145279

Product 11 of 16
ProFem Urethra Shell Pessary, size 2


HMI-no.
145282
Article-no.
DSH60-2

Registration date
01-07-2025
Last updated
08-10-2025

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. 145282

Product 12 of 16
ProFem Urethra Shell Pessary, size 3


HMI-no.
145285
Article-no.
DSH65-3

Registration date
01-07-2025
Last updated
08-10-2025

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. 145285

Product 13 of 16
ProFem Urethra Shell Pessary, size 4


HMI-no.
145288
Article-no.
DSH70-4

Registration date
01-07-2025
Last updated
08-10-2025

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. 145288

Product 14 of 16
ProFem Urethra Shell Pessary, size 5


HMI-no.
145291
Article-no.
DSH75-5

Registration date
01-07-2025
Last updated
08-10-2025

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. 145291

Product 15 of 16
ProFem Urethra Shell Pessary, size 6


HMI-no.
145294
Article-no.
DSH80-6

Registration date
01-07-2025
Last updated
08-10-2025

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. 145294

Product 16 of 16
ProFem Urethra Shell Pessary, size 7


HMI-no.
145297
Article-no.
DSH85-7

Registration date
01-07-2025
Last updated
08-10-2025

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. 145297