Manual wheelchair
by Zhongshan Aolike Medical Equipment Technology Co., Ltd. 54 variants
Ref ALK221LP-46Model ALK809, ALK809B, ALK809BJ, ,ALK809F,ALK809Y,ALK815,ALK815F,ALK874, ALK874B,ALK868, ALK875,ALK903,ALK903B, ALK903BC,ALK904, ALK904B,ALK904BC, ALK905, ALK905B,ALK905BC,ALK951,ALK951B, ALK951BC,ALK972B,ALK973LABJ, ALK983,ALK986AP,ALK863LAB,ALK863LABJ, etc
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 | Number697490123812KS 06974901230740 | Date20 Mar 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- Withdrawn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
- Manual wheelchair
- Model / Reference
- ALK809, ALK809B, ALK809BJ, ALK809F, ALK809Y, ALK815, ALK815F, ALK874, ALK874B, ALK868, ALK875, ALK903, ALK903B, ALK903BC, ALK904, ALK904B, ALK904BC, ALK905, ALK905B, ALK905BC, ALK951, ALK951B, ALK951BC, ALK972B, ALK973LABJ, ALK983, ALK986AP, ALK863LAB, ALK863LABJ, etc, ALK221LP-46
- Primary DI / UDI-DI
- 06974901230740
- Basic UDI-DI
- 697490123812KS
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000011467
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhongshan Aolike Medical Equipment Technology Co., Ltd
See all devices from Zhongshan Aolike Medical Equipment Technology 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