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Bath Lift
EUDAMEDFDA UDIClass I (EU MDR)
Ref AX07Model AX07、AX10、AX19、XY01、XY02、XY03、XY04、XY05、XY06、XY07、XY08、XY09、XY10
Identity
- Trade Name
- VOCIC FDA UDI
- Generic Name
- Patient transfer assistive bed/mobile chair FDA UDI
- Device Name
- Bath Lift EUDAMED
- Model / Reference
- AX07、AX10、AX19、XY01、XY02、XY03、XY04、XY05、XY06、XY07、XY08、XY09、XY10 EUDAMEDAX07 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976062570307 EUDAMED06976062570505 FDA UDI
- Basic UDI-DI
- 697606257BathLiftN2 EUDAMED
- FDA Product Code
- FRZ FDA UDI
- EMDN Code
- Y093303 FIXED AND ROTARY CHAIRS FOR BATH AND SHOWER EUDAMED
- GMDN Term
- Patient transfer assistive bed/mobile chair FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6775 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Bath Lift by Hangzhou Guoyuan Yanglao Technology Co., Ltd — 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 | 697606257BathLiftN2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Guoyuan Yanglao Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000034777
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 40f44b22-6187-475f-8d71-2b4639285ccb 61 fields · synced Jul 26, 2026
- FDA UDI c4846647-816f-4422-95e4-c6d29d54b6fb 32 fields · synced May 30, 2026