Upper Limb Continuous Passive Motion
by Hangzhou Zhengda Medical Co., Ltd. 5 variants
Ref CPM-A3Model CPM-A1、CPM-A2、CPM-A3、CPM-A4、CPM-A5
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697172838CPM001KE 06971728381174 | Date31 Oct 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- CPM-A1、CPM-A2、CPM-A3、CPM-A4、CPM-A5, CPM-A3
- Primary DI / UDI-DI
- 06971728381174
- Basic UDI-DI
- 697172838CPM001KE
- Direct Marketing DI
- 06971728381174
- EMDN Code
- Z120603 Passive rehabilitative gymnastics equipment
- Device Class
- Class IIa
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000044844
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Other devices from Hangzhou Zhengda 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