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LED 3SC Single Colour Surgical LED lamp
EUDAMEDClass I (EU MDR)
Ref 360/530/03Ref 360/530/01
Identity
- Trade Name
- LED 3SC Single Colour Surgical LED lamp EUDAMED
- Device Name
- Overhead Operating Lights EUDAMED
- Model / Reference
- 360/530/03 EUDAMED360/530/01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055449404983 EUDAMED05055449404358 EUDAMED
- Basic UDI-DI
- 50554494LIOWP EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
LED 3SC Single Colour Surgical LED lamp by Kenex (electro-Medical) Limited — 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 | 50554494LIOWP | Class I | Active |
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Manufacturer
- Manufacturer
- Kenex (Electro-Medical) Limited
- EUDAMED SRN
- GB-MF-000009022
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c45cff53-2216-4010-b8b2-d3efe5b0ec08 61 fields · synced Jul 22, 2026
- EUDAMED 738d7c58-850f-46a3-85c3-f91361260fd9 61 fields · synced May 19, 2026