Identity
- Trade Name
- Femigyn gel EUDAMED
- Device Name
- Femigyn gel EUDAMED
- Model / Reference
- P01275 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-P01275YS EUDAMED
- Basic UDI-DI
- B-P01275YS EUDAMED
- EMDN Code
- U0803 VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Femigyn gel by PK Benelux BV — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-P01275YS | Class IIa | Active |
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Manufacturer
- Manufacturer
- PK Benelux BV
- EUDAMED SRN
- NL-MF-000006672
Sources (1)
- EUDAMED a49fba1e-69bb-40b9-85bb-b3945b7b7104 61 fields · synced Jul 25, 2026