← Back to catalogue
LED 2SC Single colour LED minor operating lamp
EUDAMEDClass I (EU MDR)
Ref 190/230/01Ref 190/230/03
Identity
- Trade Name
- LED 2SC Single colour LED minor operating lamp EUDAMED
- Device Name
- Overhead Operating Lights EUDAMED
- Model / Reference
- 190/230/01 EUDAMED190/230/03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055449404792 EUDAMED05055449404402 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 2SC Single colour LED minor operating lamp by Kenex (electro-Medical) Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Operating room light system.
- PWDII70DF CL K3 SATX13 — MAQUET SAS · Class I
- PWDII70SF SAT AIM CL K4 12 — MAQUET SAS · Class I
- PWDII50SF AIM MHS021 K4 1116 — MAQUET SAS · Class I
- PWDII55DF CL K4 SAX0810 — MAQUET SAS · Class I
- SLS 9000 — Avante · Class II
- PWDII75SF AIM MHS021 K3 081011 — MAQUET SAS · Class I
- HarmonyAIR — STERIS CORPORATION · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kenex (Electro-Medical) Limited
- EUDAMED SRN
- GB-MF-000009022
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 84c35d68-1492-41d3-8e1c-f8dcefb866bd 61 fields · synced Oct 6, 2026
- EUDAMED 3d199f62-6e2d-496f-8a2b-65aa44705762 61 fields · synced May 17, 2026