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OceanLEDi6
EUDAMEDClass I (EU MDR)
Ref OceanLEDi6Model OceanLED6、OceanLED6B、OceanLEDi6、OceanLEDi6A、OceanLEDi6B、OceanLED66、OceanLED66B、OceanLEDi66、OceanLEDi66A、OceanLEDi66B、OceanLED666、OceanLEDi666、OceanLEDi6ABRef OceanLED i6M
Identity
- Trade Name
- OceanLEDi6 EUDAMEDOceanLED i6M EUDAMED
- Device Name
- OceanLED Surgical Light EUDAMED
- Model / Reference
- OceanLED6、OceanLED6B、OceanLEDi6、OceanLEDi6A、OceanLEDi6B、OceanLED66、OceanLED66B、OceanLEDi66、OceanLEDi66A、OceanLEDi66B、OceanLED666、OceanLEDi666、OceanLEDi6AB EUDAMEDOceanLEDi6 EUDAMEDOceanLED i6M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879265057 EUDAMED04719879265156 EUDAMED
- Basic UDI-DI
- 471987926OceanLEDNK EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS 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
OceanLEDi6 by Mediland Enterprise 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 | 471987926OceanLEDNK | Class I | Active |
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Manufacturer
- Manufacturer
- Mediland Enterprise Corporation
- EUDAMED SRN
- TW-MF-000012153
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (2)
- EUDAMED cbf179cd-80da-442c-bba8-86290daec0cf 61 fields · synced Jul 26, 2026
- EUDAMED 694308f2-4c68-47fb-a0a3-bd9c95904dd9 61 fields · synced Jul 26, 2026