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Operation Theatre Light
EUDAMEDClass I (EU MDR)
Ref OCES-999SModel Fixed operation theatre lightsRef OCES-666MModel Mobile operation theatre lightsRef OCES-999MRef OCES-108ERef OCES-666SRef OCES-108TRef OCES-108S
Identity
- Device Name
- Operation Theatre Light EUDAMED
- Model / Reference
- Fixed operation theatre lights EUDAMEDOCES-999S EUDAMEDMobile operation theatre lights EUDAMEDOCES-666M EUDAMEDOCES-999M EUDAMEDOCES-108E EUDAMEDOCES-666S EUDAMEDOCES-108T EUDAMEDOCES-108S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908025126144 EUDAMED08908025126090 EUDAMED08908025126120 EUDAMED08908025126069 EUDAMED08908025126106 EUDAMED08908025126083 EUDAMED08908025126076 EUDAMED
- Basic UDI-DI
- 8908025126OTLIGHTFIXWU EUDAMED8908025126OTLIGHTMOBX5 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMEDZ12010702 MOBILE 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 (7)
- EUDAMED 3440baf3-588b-4257-b6e7-615d53bd09fd 61 fields · synced Sep 17, 2026
- EUDAMED babc726a-3b48-4c2e-b65e-81b87c0e40f3 61 fields · synced May 16, 2026
- EUDAMED cc524a11-4864-42ed-8b41-369c5063277f 61 fields · synced May 17, 2026
- EUDAMED a2f5921f-c5cc-4e70-bab9-80a3ad1c806d 61 fields · synced May 17, 2026
- EUDAMED a82a105a-61af-4a87-951e-3c56548a0ddb 61 fields · synced May 17, 2026
- EUDAMED 1dafa798-c45a-404c-8a30-a90e39b6f43a 61 fields · synced May 18, 2026
- EUDAMED d635ca5c-5685-4c13-9c9a-9c813e1d624e 61 fields · synced May 18, 2026