Electrically powered wheelchair
by Nanjing Kangni Smart Technology Co., Ltd EUDAMED
Active
Ref K121N-CModel K101N-C,K103N-C,K104N-C,K105N-C,K106N-C,K107N-C,K108N-C,K109N-C,K110N-C,K111N-C,K112N-C,K113N-C,K114N-C,K115N-C,K116N-C,K117N-C,K118N-C,K119N-C,K120N-C,K121N-C,K122N-C,K123N-C,K124N-C, etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697266581EpwheelchairKSK3 | Date10 Feb 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Electrically powered wheelchair
- Model / Reference
- K101N-C, K103N-C, K104N-C, K105N-C, K106N-C, K107N-C, K108N-C, K109N-C, K110N-C, K111N-C, K112N-C, K113N-C, K114N-C, K115N-C, K116N-C, K117N-C, K118N-C, K119N-C, K120N-C, K121N-C, K122N-C, K123N-C, K124N-C, etc
- Primary DI / UDI-DI
- 06972665810505
- Basic UDI-DI
- 697266581EpwheelchairKSK3
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000012186
- 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