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Toileting Sling with integrated head support Large Custom Made
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3415L 90000001
Identity
- Trade Name
- Toileting Sling with integrated head support Large Custom Made EUDAMEDHandi-Move Sling FDA UDI
- Generic Name
- Patient lifting system divided leg sling FDA UDI
- Device Name
- Spreaderbar + Sling EUDAMEDToileting Sling 3415 Large Custom FDA UDI
- Model / Reference
- 3415L 90000001 EUDAMEDFDA UDI
- Description
- Toileting Sling 3415 Large Custom FDA UDI
Identifiers
- Catalog Number
- 3415L 90000001 FDA UDI
- Primary DI / UDI-DI
- 05404016610751 EUDAMEDFDA UDI
- Basic UDI-DI
- 54040166NRBSK5 EUDAMED
- FDA Product Code
- FSA FDA UDI
- EMDN Code
- V0805038002 NON-RIGID SUPPORTS FOR LIFTS (HARNESSES) EUDAMED
- GMDN Term
- Patient lifting system divided leg sling 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
Toileting Sling with integrated head support Large Custom Made by Handi-Move NV — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Manufacturer's product page: Handi-Move: innovative family business since 1982
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 | 54040166NRBSK5 | 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 d4bb7231-127a-41c8-9c95-358fedfe9439 61 fields · synced Jul 8, 2026
- FDA UDI f5561d57-0e89-4f34-9463-5bebfe460a2b 35 fields · synced May 30, 2026