Identity
- Trade Name
- OP-Film S238 EUDAMED
- Device Name
- OP-Film EUDAMED
- Model / Reference
- OP-Film EUDAMEDS238.54250-20Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719925901577 EUDAMED
- Basic UDI-DI
- 871992590200FEA EUDAMED
- EMDN Code
- T02010101 INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT 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
OP-Film S238 by Eurotape 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 | 871992590200FEA | Class I | Active |
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Manufacturer
- Manufacturer
- Eurotape B.V.
- EUDAMED SRN
- NL-MF-000001956
Sources (1)
- EUDAMED d4327ccf-d700-4d1d-92a4-ece69f253e35 61 fields · synced Jun 20, 2026