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Electric Wheelchair
EUDAMEDFDA UDIClass I (EU MDR)
Ref HBLD3-EModel HBD3A-UL001 HBD3A-UL002 HBD3A-TK002 HBD3B-UL001 HBD3B-UL002 HBD3E-HP001 HBCF- A001 HBCF- B001 HBCF- B002
by Shanghai Hubang Intelligent Rehabilitation Equipment Corporation
Identity
- Trade Name
- Hubang FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Electric Wheelchair EUDAMED
- Model / Reference
- HBD3A-UL001 HBD3A-UL002 HBD3A-TK002 HBD3B-UL001 HBD3B-UL002 HBD3E-HP001 HBCF- A001 HBCF- B001 HBCF- B002 EUDAMEDHBLD3-E EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944387010181 EUDAMEDFDA UDI
- Basic UDI-DI
- 69443870HBELE001S82 EUDAMED
- 510(k) Number
- K240913 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
- Spain 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Electric Wheelchair by Shanghai Hubang Intelligent Rehabilitation Equipment Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69443870HBELE001S82 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000028665
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (2)
- EUDAMED 6268c59c-e323-4e8a-8ade-cb1f5e23f2f5 61 fields · synced Oct 7, 2026
- FDA UDI 49ecca4f-82a8-47e5-b298-905780c9ddf3 34 fields · synced May 30, 2026