Identity
- Trade Name
- Vitadomia - Oxypharm EUDAMED
- Device Name
- Paraffin non-adherent wound contact layer EUDAMED
- Model / Reference
- 'FKRE183 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03665066001650 EUDAMED
- Basic UDI-DI
- 62220238PharmatullGC EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Vitadomia - Oxypharm by Pharmaplast — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 62220238PharmatullGC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pharmaplast
- EUDAMED SRN
- EG-MF-000004501
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED c3bbd27e-fd6d-436f-88fd-7a5fbe0d9499 61 fields · synced Jul 14, 2026
- EUDAMED 4d49afc7-6781-4b36-97f2-149e82d581ca 61 fields · synced Jul 14, 2026