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Operation Theatre Light
EUDAMEDClass I (EU MDR)
Ref OCES-666 TModel Fixed operation theatre lights
Identity
- Device Name
- Operation Theatre Light EUDAMED
- Model / Reference
- Fixed operation theatre lights EUDAMEDOCES-666 T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908025126113 EUDAMED
- Basic UDI-DI
- 8908025126OTLIGHTFIXWU EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I 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
Operation Theatre Light by Surgical Equipment Co. — 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 | 8908025126OTLIGHTFIXWU | Class I | Active |
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Manufacturer
- Manufacturer
- Surgical Equipment Co.
- EUDAMED SRN
- IN-MF-000043933
- Authorised Representative
- OMC NI MEDICAL LIMITED XI-AR-000019483
Sources (1)
- EUDAMED 5c7b15d4-98eb-4b29-b688-a65b41545250 61 fields · synced Jun 19, 2026