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RealMicro 4K
EUDAMEDClass I (EU MDR)
Ref VOMS-400 OPHModel VOMS-400 and VOMS-400 OPH
Identity
- Trade Name
- RealMicro 4K EUDAMED
- Device Name
- 3D Video Digital Operating Microscopy System EUDAMED
- Model / Reference
- VOMS-400 and VOMS-400 OPH EUDAMEDVOMS-400 OPH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800065717064 EUDAMED
- Basic UDI-DI
- 88000657VOMS-4002V EUDAMED
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES 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
RealMicro 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 | 88000657VOMS-4002V | 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 842a542a-1a40-4d2a-82da-8c42ae4a1254 61 fields · synced Jul 18, 2026