Identity
- Trade Name
- OPF-1 EUDAMED
- Device Name
- Endoscopy Cart EUDAMED
- Model / Reference
- 106160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060671730137 EUDAMED
- Basic UDI-DI
- 506067173ENDC000001RM EUDAMED
- Direct Marketing DI
- 05060671730137 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Opf-1 by Endocarts International Limited — 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 | 506067173ENDC000001RM | Class I | Active |
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Manufacturer
- Manufacturer
- Endocarts International Limited
- EUDAMED SRN
- GB-MF-000004309
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED 02d57e73-1d32-4f5a-88aa-b74593cb2386 61 fields · synced Jul 11, 2026