Identity
- Trade Name
- DR,FEN,SMS,330X211,F10 EUDAMED
- Device Name
- Medical Drapes, Medical Gowns and Medical Equipment Covers, to be sterilised before use EUDAMED
- Model / Reference
- 1302555 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08710685108763 EUDAMED
- Basic UDI-DI
- 8710685TF05001002QX EUDAMED
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Dr, Fen, Sms, 330x211, F10 by Medica Europe B.V. — 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 | 8710685TF05001002QX | Class I | Active |
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Manufacturer
- Manufacturer
- Medica Europe B.V.
- EUDAMED SRN
- NL-MF-000000118
Sources (1)
- EUDAMED 2285d56d-d51f-454f-8fce-1fde89ad8ed2 61 fields · synced Jul 20, 2026