Identity
- Trade Name
- Protectfilm® Gentle EUDAMED
- Device Name
- Gentle Dressings EUDAMED
- Model / Reference
- PROTG100160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06222023809109 EUDAMED
- Basic UDI-DI
- 62220238GentleDressingsVU EUDAMED
- EMDN Code
- M04010101,M04010102 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Protectfilm® Gentle 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 | 62220238GentleDressingsVU | 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 9e54a78b-9f63-492e-9bdb-a22a6b0161c2 61 fields · synced Sep 17, 2026