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Spreaderbar, low height version, Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2115 00000002
Identity
- Trade Name
- Spreaderbar, low height version, Large EUDAMEDHandi-Move Spreaderbar FDA UDI
- Generic Name
- Overhead track patient lifting/transfer system FDA UDI
- Device Name
- Spreaderbar + Sling EUDAMEDSpreaderbar 2115 FDA UDI
- Model / Reference
- 2115 00000002 EUDAMEDFDA UDI
- Description
- Spreaderbar 2115 FDA UDI
Identifiers
- Catalog Number
- 2115 00000002 FDA UDI
- Primary DI / UDI-DI
- 05404016610294 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
- 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
Spreaderbar, low height version, Large 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 | 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 f20610cf-2a86-43fc-8d09-e209b8ff8d40 61 fields · synced Jul 30, 2026
- FDA UDI 3824a2b2-e268-4a59-be71-5be4301b82cc 35 fields · synced May 29, 2026