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Orled/S
EUDAMEDClass I (EU MDR)
Ref ORLED/SModel ORLED/S、ORLED/D、ORLED/T、ORLED/DA、ORLED/DB
Identity
- Trade Name
- ORLED/S EUDAMED
- Device Name
- MediLED ORLED Surgical Light EUDAMED
- Model / Reference
- ORLED/S、ORLED/D、ORLED/T、ORLED/DA、ORLED/DB EUDAMEDORLED/S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879262414 EUDAMED
- Basic UDI-DI
- 471987926ORLEDST 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
Orled/S 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 | 471987926ORLEDST | 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 (1)
- EUDAMED b495e9fb-ff84-4518-bede-b81d4d6ca4c9 61 fields · synced Jun 19, 2026