Identity
- Trade Name
- Points 3841 EUDAMEDHandi-Move Rail System FDA UDI
- Generic Name
- Overhead track patient lifting/transfer system FDA UDI
- Device Name
- Ceiling Motor "28xx" EUDAMEDPoints 3841 FDA UDI
- Model / Reference
- 3841 00000002 EUDAMEDFDA UDI
- Description
- Points 3841 FDA UDI
Identifiers
- Catalog Number
- 3841 00000002 FDA UDI
- Primary DI / UDI-DI
- 05404016612847 EUDAMEDFDA UDI
- Basic UDI-DI
- 54040166CTLFH6 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
- Belgium 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Points 3841 by Handi-Move NV — 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 | 54040166CTLFH6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Handi-Move NV
- EUDAMED SRN
- BE-MF-000016949
Sources (2)
- EUDAMED f0cf03e7-619e-49d7-bb16-c1f09e317c4e 61 fields · synced Jun 18, 2026
- FDA UDI e03f2989-6f61-4a15-95cb-465fdcf99074 35 fields · synced May 30, 2026