Upper And Lower Limbs Active And Passive Rehabilitation Exercise Trainer
by MediRobotic technology Co., Ltd. 3 variants
Ref ZEPU-AI7DModel ZEPU-AI7B, ZEPU-AI7A, ZEPU-K2000F, ZEPU-K2000E, ZEPU-K2000A
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 | Number697774623CE003GX 06977746230128 | Date28 Aug 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- Withdrawn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
- Device Name
- Upper And Lower Limbs Active And Passive Rehabilitation Exercise Trainer
- Model / Reference
- ZEPU-AI7B, ZEPU-AI7A, ZEPU-K2000F, ZEPU-K2000E, ZEPU-K2000A, ZEPU-AI7D
- Primary DI / UDI-DI
- 06977746230128
- Basic UDI-DI
- 697774623CE003GX
- EMDN Code
- Z120603 Passive rehabilitative gymnastics equipment
- Device Class
- Class IIa
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000042421
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from MediRobotic 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