Universal Light Handle, for use with ‘Gettinge/CASTLE-GRAY2300-2400-2800’
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- LITEX FDA UDI
- Generic Name
- Medical equipment handle cover adaptor FDA UDI
- Device Name
- Universal Light Handle, for use with ‘Gettinge/CASTLE-GRAY2300-2400-2800’ EUDAMED
- Model / Reference
- 3600-1 EUDAMED3600-8 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060792970863 EUDAMEDFDA UDI
- Basic UDI-DI
- 506079297ULHANDULAU7 EUDAMED
- FDA Product Code
- FTA FDA UDI
- EMDN Code
- Z12010780 SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Medical equipment handle cover adaptor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Market of Registration
- France 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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Universal Light Handle, for use with 'Gettinge/CASTLE-GRAY2300-2400-2800', is a medical device designed for low-light conditions. This light handle features a durable and ergonomic design, making it ideal for patients requiring night vision assistance. Developed by Litex Manufacturing, Inc., this device combines advanced optics and precise mechanics to provide reliable illumination.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506079297ULHANDULAU7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Litex Manufacturing, Inc.
- EUDAMED SRN
- US-MF-000005939
- Authorised Representative
- Medical Device Management Ltd IE-AR-000002496
Sources (2)
- EUDAMED 9d5f335d-f822-49ec-889c-b821f5f1771a 61 fields · synced Jun 21, 2026
- FDA UDI 93e8eb2e-b28b-4aef-95e1-838e151c9d3c 32 fields · synced May 30, 2026