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Medical Camera Head
EUDAMEDClass I (EU MDR)
Ref CH-2200-5Ref CG-2200-3Ref CH-2200-3
Identity
- Trade Name
- Medical Camera Head EUDAMED
- Device Name
- Endoscope Camera System EUDAMED
- Model / Reference
- CH-2200-5 EUDAMEDCG-2200-3 EUDAMEDCH-2200-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800138500456 EUDAMED08800138500463 EUDAMED08800138500449 EUDAMED
- Basic UDI-DI
- 08800138CCU-2200XW EUDAMED
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Medical Camera Head by M.I.ONE Co., Ltd. — 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 | 08800138CCU-2200XW | Class I | Active |
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Manufacturer
- Manufacturer
- M.I.ONE Co., Ltd.
- EUDAMED SRN
- KR-MF-000050358
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (3)
- EUDAMED c52b8d45-e3ed-4fac-879f-95f152ce06cb 61 fields · synced Jul 30, 2026
- EUDAMED 872f9cf8-651f-41d5-bc07-5f3827365302 61 fields · synced May 18, 2026
- EUDAMED 431fca06-eb3b-46f3-8b91-ec555e0c401c 61 fields · synced May 18, 2026