← Back to catalogue
LED 6MC Lamp and suspension arm only (for use with a Kenex celling radiation sh…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 610/530/01
Identity
- Trade Name
- LED 6MC Lamp and suspension arm only (for use with a Kenex celling radiation shield) EUDAMEDKENEX FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- Overhead Operating Lights EUDAMEDLED 6MC Lamp and suspension arm only (for use with a Kenex celling radiation shield) FDA UDI
- Model / Reference
- 610/530/01 EUDAMEDFDA UDI
- Description
- LED 6MC Lamp and suspension arm only (for use with a Kenex celling radiation shield) FDA UDI
Identifiers
- Catalog Number
- 610/530/01 FDA UDI
- Primary DI / UDI-DI
- 05055449410755 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494LIOWP EUDAMED
- FDA Product Code
- FSY FDA UDI
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Operating room light system
LED 6MC Lamp and suspension arm only (for use with a Kenex celling radiation sh… by Kenex (electro-Medical) Limited — Class I — MDR, FDA UDI — listed in…
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
- Operating Light — Weihai Wego Qiquan Medical Equipment Co., Ltd. · Class I
- PWDII75SF AIM MHS021 K3 081011 — MAQUET SAS · Class I
- HarmonyAIR — STERIS CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50554494LIOWP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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 df50a494-0f86-4783-bde1-145bba7003ac 61 fields · synced Oct 6, 2026
- FDA UDI ec4bbf43-ec59-4091-9f69-65ee96a53a75 34 fields · synced May 30, 2026