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Gynomunal® Gel 15mL (SE)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 08430308132936Model TD-04
Identity
- Trade Name
- Gynomunal® Gel 15mL (SE) EUDAMED
- Device Name
- Gynomunal® Gel 15mL EUDAMED
- Model / Reference
- TD-04 EUDAMED08430308132936 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08430308132936 EUDAMED
- Basic UDI-DI
- B-08430308132936 EUDAMED
- EMDN Code
- U0803 VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Gynomunal® Gel 15mL (SE) by Polichem SA, Lussemburgo, succursale di Mendrisio — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143349 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08430308132936 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Polichem SA, Lussemburgo, succursale di Mendrisio
- EUDAMED SRN
- CH-MF-000025294
- Authorised Representative
- Almirall S.A. ES-AR-000019145
Sources (2)
- EUDAMED 52997abe-cbef-4fa1-9ce8-02cd4590bf58 61 fields · synced Oct 6, 2026
- FDA 510(k) K143349 1 fields · synced May 18, 2026