Identity
- Trade Name
- RealEndo EUDAMED
- Device Name
- Video Endoscopy System EUDAMED
- Model / Reference
- MiDAS I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800065713035 EUDAMED
- Basic UDI-DI
- 88000657MiDASIVLSCOTR2 EUDAMED
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
RealEndo by Sometech Inc. — 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 | 88000657MiDASIVLSCOTR2 | Class I | Active |
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Manufacturer
- Manufacturer
- Sometech Inc.
- EUDAMED SRN
- KR-MF-000023076
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED ff21d9a8-907d-4f3c-953f-df1959560e02 61 fields · synced Jul 17, 2026