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LED 300DF SC Lamp and suspension arm only (for use with a Kenex celling radiati…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 340/631/01
Identity
- Trade Name
- LED 300DF SC 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 300DF SC Lamp and suspension arm only (for use with a Kenex celling radiation shield) FDA UDI
- Model / Reference
- 340/631/01 EUDAMEDFDA UDI
- Description
- LED 300DF SC Lamp and suspension arm only (for use with a Kenex celling radiation shield) FDA UDI
Identifiers
- Catalog Number
- 340/631/01 FDA UDI
- Primary DI / UDI-DI
- 05055449410366 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 300DF SC Lamp and suspension arm only (for use with a Kenex celling radiati… by Kenex (electro-Medical) Limited — Class I — MDR, FDA UDI — listed in…
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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 | 50554494LIOWP | 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 ef61694e-865e-439d-bdb4-8e10f88a8d73 61 fields · synced Oct 6, 2026
- FDA UDI 85a85945-9457-4229-a046-04df9d85323d 34 fields · synced May 29, 2026