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Operation Theatre Light
EUDAMEDClass I (EU MDR)
Ref OCES-999SModel Fixed operation theatre lights
Identity
- Device Name
- Operation Theatre Light EUDAMED
- Model / Reference
- Fixed operation theatre lights EUDAMEDOCES-999S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908025126137 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
Operation Theatre Light by Surgical Equipment Co. — 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 | 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 3c325c46-c153-45cc-91be-b2010ec5c6f5 61 fields · synced Jun 17, 2026