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Real Endo 4K and EndoPik 4K
EUDAMEDClass I (EU MDR)
Ref VLS-400 and VES-400Model MiDAS II (VLS-400, VES-400)
Identity
- Trade Name
- Real Endo 4K and EndoPik 4K EUDAMED
- Device Name
- Video Endoscopy System EUDAMED
- Model / Reference
- MiDAS II (VLS-400, VES-400) EUDAMEDVLS-400 and VES-400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800065714025 EUDAMED
- Basic UDI-DI
- 88000657MiDASIIVLSVESYA EUDAMED
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Real Endo 4K and EndoPik 4K 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 | 88000657MiDASIIVLSVESYA | 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 7fee593f-a63f-42fb-a410-19afe2a0433a 61 fields · synced Jul 21, 2026