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Om-9
EUDAMEDClass I (EU MDR)
Ref B14004Ref OM-9Model OM-6、OM-9、OM-19
by Takagi seiko
Identity
- Trade Name
- OM-9 EUDAMEDOperating Microscopes OM-9 EUDAMED
- Device Name
- Operating Microscopes EUDAMED
- Model / Reference
- B14004 EUDAMEDOM-6、OM-9、OM-19 EUDAMEDOM-9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560323640476 EUDAMED
- Basic UDI-DI
- 4560323640028D EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDSpain 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
Om-9 by Takagi seiko — 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 | 4560323640028D | Class I | Active |
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Manufacturer
- Manufacturer
- Takagi seiko
- EUDAMED SRN
- JP-MF-000008791
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 524de0f7-119b-4432-ba78-d28f728b1766 61 fields · synced Jun 19, 2026
- EUDAMED 900bbc7b-0dd7-4a41-af7d-c4de0d565c2b 61 fields · synced Jun 19, 2026