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Electrically Powered Wheelchair
EUDAMEDFDA UDIClass I (EU MDR)
Ref YA12-16Model YA12-9、YA12-5、YA12-7、YA12-16、YA12-10、YS16-1
Identity
- Trade Name
- Yurob FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Electrically Powered Wheelchair EUDAMED
- Model / Reference
- YA12-9、YA12-5、YA12-7、YA12-16、YA12-10、YS16-1 EUDAMEDYA12-16 EUDAMEDYLB-W-0812-A02 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974573540055 EUDAMEDFDA UDI
- Basic UDI-DI
- 697457354Ewheelchair4H EUDAMED
- 510(k) Number
- K232193 FDA UDI
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
- GMDN Term
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3860 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Electrically Powered Wheelchair by Yurob Rehabilitation Medical 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 | 697457354Ewheelchair4H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Yurob Rehabilitation Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000033497
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 6397a8a0-5669-424a-8fb9-ad4bef2eb4aa 61 fields · synced Oct 6, 2026
- FDA UDI a3add749-acdc-42b0-9365-74ae341be55f 33 fields · synced May 30, 2026