Rollator
by Yongkang Hengyi Vehicle Co., Ltd EUDAMED
Active
Ref HC618, HC617, HA601Model HA601, HA602, HA603, HA604, HA605, HA606, HA607, HA608, HA609, HA610, HA611, HA612, HA613, HA614, HA615, HA616, HC617, HC618, HC619, HC620, HC621, HC622, HC623, HC624, HC625
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697747409REU01T8 | Date20 Jun 2024 | 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- Withdrawn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
- Rollator
- Model / Reference
- HA601, HA602, HA603, HA604, HA605, HA606, HA607, HA608, HA609, HA610, HA611, HA612, HA613, HA614, HA615, HA616, HC617, HC618, HC619, HC620, HC621, HC622, HC623, HC624, HC625
- Primary DI / UDI-DI
- 06977474091176, 06977474091169, 06977474091008
- Basic UDI-DI
- 697747409REU01T8
- EMDN Code
- Y122127, Y120612
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000042716
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Yongkang Hengyi Vehicle 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