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Ip090195prn
EUDAMEDFDA UDIClass I (EU MDR)
Ref IP090195PRNModel B-ASSIST
by GBUK Group
Identity
- Trade Name
- Banana FDA UDI
- Generic Name
- Patient transfer/turning sheet, single-use FDA UDI
- Device Name
- Banana, Intoprone, Single Patient Use 90cm x 190cm FDA UDI
- Model / Reference
- B-ASSIST EUDAMEDIP090195PRN EUDAMEDFDA UDI
- Description
- Banana, Intoprone, Single Patient Use 90cm x 190cm FDA UDI
Identifiers
- Catalog Number
- IP090195PRN FDA UDI
- Primary DI / UDI-DI
- 05060405743860 EUDAMEDFDA UDI
- Basic UDI-DI
- 506040574ProningPF EUDAMED
- FDA Product Code
- FMR FDA UDI
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Patient transfer/turning sheet, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6785 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Ip090195prn 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 | 506040574ProningPF | 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 fe342971-7f27-4697-a78c-d623ad6ba476 61 fields · synced Jul 8, 2026
- FDA UDI 72151fbf-e31a-4e6d-bec6-b29a42182c83 34 fields · synced May 30, 2026