LED130F Focusable LED Examination Lamp
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- LED130F Focusable LED Examination Lamp EUDAMEDKENEX FDA UDI
- Generic Name
- Fixed examination/treatment room light FDA UDI
- Device Name
- Overhead examination/operating lighting EUDAMEDLED 130F - Focusable LED examination lamps FDA UDI
- Model / Reference
- 300/L-LED130F EUDAMEDFDA UDI
- Description
- LED 130F - Focusable LED examination lamps FDA UDI
Identifiers
- Catalog Number
- 300/L-LED130F FDA UDI
- Primary DI / UDI-DI
- 05055449405461 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494LIMWK EUDAMED
- FDA Product Code
- KZF FDA UDI
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
- GMDN Term
- Fixed examination/treatment room light FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6320 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Operating room light system
LED130F Focusable LED Examination Lamp by Kenex (electro-Medical) Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50554494LIMWK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 386bd449-c3ff-4a19-9433-ab6880fed95c 61 fields · synced Jun 19, 2026
- FDA UDI a281fc4b-d764-43eb-9d96-768b0e10c7c9 34 fields · synced May 30, 2026