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B-Sspul-Xxl
EUDAMEDFDA UDIClass I (EU MDR)
Ref B-SSPUL-XXLModel B-SSPUL-S
by GBUK Group
Identity
- Trade Name
- Banana FDA UDI
- Generic Name
- Solid-seat mobile patient lifting system seat FDA UDI
- Device Name
- Banana, Loop, Sling, Single Patient Use Extra Extra Large FDA UDI
- Model / Reference
- B-SSPUL-S EUDAMEDB-SSPUL-XXL EUDAMEDFDA UDI
- Description
- Banana, Loop, Sling, Single Patient Use Extra Extra Large FDA UDI
Identifiers
- Catalog Number
- B-SSPUL-XXL FDA UDI
- Primary DI / UDI-DI
- 05060405746236 EUDAMEDFDA UDI
- Basic UDI-DI
- 506040574SlingsZB EUDAMED
- FDA Product Code
- INE FDA UDI
- EMDN Code
- V0805038002 NON-RIGID SUPPORTS FOR LIFTS (HARNESSES) EUDAMED
- GMDN Term
- Solid-seat mobile patient lifting system seat FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3910 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
B-Sspul-Xxl by GBUK Group — 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 | 506040574SlingsZB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GBUK Group
- EUDAMED SRN
- GB-MF-000002238
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 2dcfa790-2c9f-479e-bf98-9e99458cee7b 61 fields · synced Jun 19, 2026
- FDA UDI 01c8a42a-1f43-42b7-b3aa-b3671189dcd7 34 fields · synced May 30, 2026