Electric wheelchair
by Freewheel Medical Co., Ltd EUDAMED
Active
Ref FW204-ERModel FW001，FW002，FW003，FW004，FW005，FW006 FW101-C，FW101-M，FW101-A, FW101-S FW102-C，FW102-M，FW102-A, FW102-S FW103-C，FW103-M，FW103-A, FW103-S FW104-C，FW104-M，FW104-A, FW104-S,etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697825420FW01M6 | Date24 Jan 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- Withdrawn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
- Electric wheelchair
- Model / Reference
- FW001，FW002，FW003，FW004，FW005，FW006 FW101-C，FW101-M，FW101-A, FW101-S FW102-C，FW102-M，FW102-A, FW102-S FW103-C，FW103-M，FW103-A, FW103-S FW104-C，FW104-M，FW104-A, FW104-S, etc, FW204-ER
- Primary DI / UDI-DI
- 06978254200375
- Basic UDI-DI
- 697825420FW01M6
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000046098
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Freewheel Medical Co., Ltd
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