ProFem Shell Pessary




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

Documents
Brochure


The product series contains 16 products.

» Summarize specifications

Product 1 of 16
Profem Shell Pessary size 0, 50 mm


HMI-no.
146095
Article-no.
CP50/18-0

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

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. 146095

Product 2 of 16
Profem Shell Pessary size 1, 55 mm


HMI-no.
146098
Article-no.
CP55/23-1

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

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. 146098

Product 3 of 16
Profem Shell Pessary size 2, 60 mm


HMI-no.
146101
Article-no.
CP60/28-2

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

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. 146101

Product 4 of 16
Profem Shell Pessary size 3, 65 mm


HMI-no.
146104
Article-no.
CP65/33-3

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

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. 146104

Product 5 of 16
Profem Shell Pessary size 4, 70 mm


HMI-no.
146107
Article-no.
CP70/38-4

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

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. 146107

Product 6 of 16
Profem Shell Pessary size 5, 75 mm


HMI-no.
146110
Article-no.
CP75/43-5

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

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. 146110

Product 7 of 16
Profem Shell Pessary size 6, 80 mm


HMI-no.
146114
Article-no.
CP80/48-6

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

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. 146114

Product 8 of 16
Profem Shell Pessary size 7, 85 mm


HMI-no.
146117
Article-no.
CP85/52-7

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

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. 146117

Product 9 of 16
Profem Shell Pessary with support size 0, 50 mm


HMI-no.
146120
Article-no.
CP50/18S-0

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

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. 146120

Product 10 of 16
Profem Shell Pessary with support size 1, 55 mm


HMI-no.
146123
Article-no.
CP55/23S-1

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

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. 146123

Product 11 of 16
Profem Shell Pessary with support size 2, 60 mm


HMI-no.
146126
Article-no.
CP60/28S-2

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

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. 146126

Product 12 of 16
Profem Shell Pessary with support size 3, 65 mm


HMI-no.
146129
Article-no.
CP65/33S-3

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

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. 146129

Product 13 of 16
Profem Shell Pessary with support size 4, 70 mm


HMI-no.
146132
Article-no.
CP70/38S-4

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

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. 146132

Product 14 of 16
Profem Shell Pessary with support size 5, 75 mm


HMI-no.
146135
Article-no.
CP75/43S-5

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

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. 146135

Product 15 of 16
Profem Shell Pessary with support size 6, 80 mm


HMI-no.
146138
Article-no.
CP80/48S-6

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

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. 146138

Product 16 of 16
Profem Shell Pessary with support size 7, 85 mm


HMI-no.
146142
Article-no.
CP85/52S-7

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

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. 146142