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OceanLED6B
EUDAMEDClass I (EU MDR)
Ref OceanLED6BModel OceanLED6、OceanLED6B、OceanLEDi6、OceanLEDi6A、OceanLEDi6B、OceanLED66、OceanLED66B、OceanLEDi66、OceanLEDi66A、OceanLEDi66B、OceanLED666、OceanLEDi666、OceanLEDi6ABRef OceanLED 6MB
Identity
- Trade Name
- OceanLED6B EUDAMEDOceanLED 6MB EUDAMED
- Device Name
- OceanLED Surgical Light EUDAMED
- Model / Reference
- OceanLED6、OceanLED6B、OceanLEDi6、OceanLEDi6A、OceanLEDi6B、OceanLED66、OceanLED66B、OceanLEDi66、OceanLEDi66A、OceanLEDi66B、OceanLED666、OceanLEDi666、OceanLEDi6AB EUDAMEDOceanLED6B EUDAMEDOceanLED 6MB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879265033 EUDAMED04719879265149 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
Category: Operating room light system
OceanLED6B by Mediland Enterprise Corporation — 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 | 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 bf44699c-52a0-41b4-80ae-8a6c0ee01cb6 61 fields · synced Jul 25, 2026
- EUDAMED 0431828c-772e-4057-ad4b-e8d26a9154a3 61 fields · synced Jul 25, 2026