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Operation Microscope Oms-800
EUDAMEDClass I (EU MDR)
Ref OMS-800 StandardRef OMS-800 OFFISSRef OMS-800 Pro
Identity
- Trade Name
- OPERATION MICROSCOPE OMS-800 EUDAMED
- Device Name
- OPERATION MICROSCOPE EUDAMED
- Model / Reference
- OMS-800 Standard EUDAMEDOMS-800 OFFISS EUDAMEDOMS-800 Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562123289480 EUDAMED04562123289503 EUDAMED04562123289497 EUDAMED
- Basic UDI-DI
- 4560126260130U5 EUDAMED
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES 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
Operation Microscope Oms-800 by Topcon Corporation — 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 | 4560126260130U5 | Class I | Active |
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Manufacturer
- Manufacturer
- Topcon Corporation
- EUDAMED SRN
- JP-MF-000003928
- Authorised Representative
- Topcon Europe Medical BV NL-AR-000000441
Sources (3)
- EUDAMED 345d1762-eda2-4194-a091-8c337aed2dee 61 fields · synced Aug 1, 2026
- EUDAMED 932cef88-911b-4126-99af-ba29476a7704 61 fields · synced May 17, 2026
- EUDAMED fb542c3a-f025-44b0-a075-34567edb9e8f 61 fields · synced May 18, 2026