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LED 150F Focusable LED examination and small operating lamps
EUDAMEDFDA UDIClass I (EU MDR)
Ref 300/L-LED150F
Identity
- Trade Name
- LED 150F Focusable LED examination and small operating lamps EUDAMEDKENEX FDA UDI
- Generic Name
- Fixed examination/treatment room light FDA UDI
- Device Name
- Overhead examination/operating lighting EUDAMEDLED 150F Focusable LED examination and small operating lamps FDA UDI
- Model / Reference
- 300/L-LED150F EUDAMEDFDA UDI
- Description
- LED 150F Focusable LED examination and small operating lamps FDA UDI
Identifiers
- Catalog Number
- 300/L-LED150F FDA UDI
- Primary DI / UDI-DI
- 05055449401760 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
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 150F Focusable LED examination and small operating lamps by Kenex (electro-Medical) Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 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 ea0c0999-7a5d-4b1a-8701-f7606e1be61a 61 fields · synced Jul 9, 2026
- FDA UDI bb747fe5-5ddb-4d6b-a525-d1ccd41c447d 34 fields · synced May 30, 2026