Upper and Lower Limbs Active And Passive Rehabillitation Exercise Trainer
by Shandong Zepu Medical Technology Co., Ltd 12 variants
Ref ZEPU-K2000DModel ZEPU-K2000A,ZEPU-K2000B,ZEPU-K2000C,ZEPU-K2000D,ZEPU-K2000E,ZEPU-K2000K,ZEPU-K2000F,ZEPU-K2000G,ZEPU-K2000H,ZEPU-AI7A,ZEPU-AI7B,ZEPU-AI7D
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 | Number697663257UALLAAPRETYX 06976632570126 | Date2 Apr 2024 | 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- Withdrawn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
- Upper and Lower Limbs Active And Passive Rehabillitation Exercise Trainer
- Model / Reference
- ZEPU-K2000A, ZEPU-K2000B, ZEPU-K2000C, ZEPU-K2000D, ZEPU-K2000E, ZEPU-K2000K, ZEPU-K2000F, ZEPU-K2000G, ZEPU-K2000H, ZEPU-AI7A, ZEPU-AI7B, ZEPU-AI7D
- Primary DI / UDI-DI
- 06976632570126
- Basic UDI-DI
- 697663257UALLAAPRETYX
- EMDN Code
- Y0504 Arms, torso and legs re-education devices
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000037255
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shandong Zepu Medical Technology Co., Ltd
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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