Identity
- Trade Name
- Optimelle – IV - Expad EUDAMED
- Device Name
- Post-operative dressings EUDAMED
- Model / Reference
- FSCI171 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04603727958638 EUDAMED
- Basic UDI-DI
- 62220238PharmaPore8R EUDAMED
- EMDN Code
- M04010101,M04010102 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Optimelle – IV - Expad by Pharmaplast — Class I — 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 | 62220238PharmaPore8R | Class I | Active |
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Manufacturer
- Manufacturer
- Pharmaplast
- EUDAMED SRN
- EG-MF-000004501
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (1)
- EUDAMED beb7e76a-1bf5-41a2-9b8c-90125e80299d 61 fields · synced Aug 2, 2026