Identity
- Trade Name
- Winncare EUDAMEDLuna IPX4 200 kg Fixed - Winncare FDA UDI
- Generic Name
- Overhead track patient lifting/transfer system FDA UDI
- Device Name
- Ceiling Hoist EUDAMEDLuna IPX4 Fixed Ceiling Lift. Wired hand controller. Standard with Two-point spreader bar. Safe Working Load 440 Ib (200 kg). FDA UDI
- Model / Reference
- Luna IPX4 EUDAMED015-03026 EUDAMEDFDA UDI
- Description
- Luna IPX4 Fixed Ceiling Lift. Wired hand controller. Standard with Two-point spreader bar. Safe Working Load 440 Ib (200 kg). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05740008101396 EUDAMEDFDA UDI
- Basic UDI-DI
- 5740008101001SB EUDAMED
- Direct Marketing DI
- 05740008101396 EUDAMED
- FDA Product Code
- FSA FDA UDI
- EMDN Code
- V08050302 ELECTRIC FIXED LIFTS EUDAMED
- GMDN Term
- Overhead track patient lifting/transfer system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5510 FDA UDI
- Market of Registration
- Denmark 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Height — 130 Decimeter FDA UDIWeight — 6700 Gram FDA UDIOuter Diameter — 320 Millimeter FDA UDI
Winncare by Winncare Nordic — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 5740008101001SB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Winncare Nordic
- EUDAMED SRN
- DK-MF-000002147
Sources (2)
- EUDAMED 7923f7b1-0a18-467c-b270-17d90c3550b4 61 fields · synced Jul 29, 2026
- FDA UDI 2b257880-6a42-49e4-8525-122c9c959844 35 fields · synced May 30, 2026