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Rosaltrof® Gel 15mL (ES)
EUDAMEDClass IIa (EU MDR)
Ref 08430308133230Model TD-04
Identity
- Trade Name
- Rosaltrof® Gel 15mL (ES) EUDAMED
- Device Name
- Gynomunal® Gel 15mL EUDAMED
- Model / Reference
- TD-04 EUDAMED08430308133230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08430308133230 EUDAMED
- Basic UDI-DI
- B-08430308133230 EUDAMED
- EMDN Code
- U0803 VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Rosaltrof® Gel 15mL (ES) by Polichem SA, Lussemburgo, succursale di Mendrisio — 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-08430308133230 | 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 (1)
- EUDAMED fd8d423c-15c8-4116-90a4-5c9a1e5016f0 61 fields · synced Jul 13, 2026