image plate scanner
by Inpixel Medical Technology Co., Ltd 2 variants
Ref IPS1Model IPS
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 | Number697636538999R9 06976365389996 | Date3 Jan 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- Withdrawn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
- Model / Reference
- IPS, IPS1
- Primary DI / UDI-DI
- 06976365389996
- Basic UDI-DI
- 697636538999R9
- Direct Marketing DI
- 06976365389996
- EMDN Code
- Z110601 Laser imaging scanner
- Device Class
- Class I
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- CN-MF-000039577
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Inpixel Medical 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