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Universal Light Handle, for use with ‘Gettinge/CASTLE-GRAY2300-2400-2800’
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3600-53Model 3600-1
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 EUDAMED3600-53 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060792970511 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
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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Universal Light Handle, for use with ‘Gettinge/CASTLE-GRAY2300-2400-2800’ by Litex Manufacturing, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 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 b7ee5756-dd6c-4f32-9fd8-6bbc7d107d1d 61 fields · synced Sep 18, 2026
- FDA UDI a18becfd-598a-4189-ba25-0e02e5977578 32 fields · synced May 30, 2026