Identity
- Trade Name
- Light source EUDAMED
- Device Name
- Endoscope Camera System EUDAMED
- Model / Reference
- LED-150C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800138500081 EUDAMED
- Basic UDI-DI
- 08800138CCU-2200XW EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY 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
Category: Endoscopic light source unit, line-powered
Light source by M.I.ONE Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (1)
- EUDAMED e30a1d11-1b4e-4a4a-b67a-98f6460a6a00 61 fields · synced Jul 17, 2026