Transfer Chair (Moving Machine)
by Shenzhen Mai Kangxin Medical Robot Co., Ltd.
Ref MKX-YWJ-02BModel MKX-YWJ-01A
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number697515075MKX0102RK 06975150750102 | Date20 Jul 2023 | StatusActive |
| United States | GUDID listing GUDID | Number06975150750102 | Date6 Apr 2023 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Transfer Chair (Moving Machine) EUDAMEDMaikangxin GUDID
- Generic Name
- Patient transfer assistive bed/mobile chair
- Model / Reference
- MKX-YWJ-01A, MKX-YWJ-02B
- Primary DI / UDI-DI
- 06975150750102
- Basic UDI-DI
- 697515075MKX0102RK
- FDA Product Code
- IKX
- EMDN Code
- V080502 Patient transfer chairs
- GMDN Term
- Patient transfer assistive bed/mobile chair
- Device Class
- Class I
- Regulation Number
- 890.5050
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- CN-MF-000027762
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (21)
- Sterile: No
- Single Use: 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No