Wheelchair Power Attachment
by Boneng Electric Appliance (Changzhou) Co., Ltd. 20 variants
Ref EWH001Model EWH001,EWH002,EWH003,EWH004,EWH005,EWH006,EWH007.EWH008,EWH009,EWH010,EWH011,EWH012,EWH013,EWH014,EWH015,EWH016,EWH017,EWH018,EWH019,EWH020
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697826824EWHEU017L 06978268240008 | Date22 Jan 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Wheelchair Power Attachment
- Model / Reference
- EWH001, EWH002, EWH003, EWH004, EWH005, EWH006, EWH007.EWH008, EWH009, EWH010, EWH011, EWH012, EWH013, EWH014, EWH015, EWH016, EWH017, EWH018, EWH019, EWH020
- Primary DI / UDI-DI
- 06978268240008
- Basic UDI-DI
- 697826824EWHEU017L
- EMDN Code
- Y122411 Wheelchair unicycle
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000046049
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No