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Endoscope with Light source
EUDAMEDClass I (EU MDR)
Ref LED-Z1403Ref LED-Z1407Ref LED-Z1400
Identity
- Trade Name
- Endoscope with Light source EUDAMED
- Device Name
- Wireless-CAM EUDAMED
- Model / Reference
- LED-Z1403 EUDAMEDLED-Z1407 EUDAMEDLED-Z1400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800138500333 EUDAMED08800138500340 EUDAMED08800138500326 EUDAMED
- Basic UDI-DI
- 08800138CW-2000UY EUDAMED
- EMDN Code
- Z12020402,Z12020405 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
Endoscope with Light source 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 | 08800138CW-2000UY | 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 f89c8c01-0d06-47e0-a428-c17417eefbe1 61 fields · synced Jul 25, 2026
- EUDAMED b8348647-7aae-45b7-9e76-8fbe03eb9021 61 fields · synced May 17, 2026
- EUDAMED 0694bf40-dc66-476e-9876-c089867162d5 61 fields · synced May 18, 2026