LED X-ray film viewer
by Hunan Mplent Optoelectronics Technology Co., Ltd
Model ZG-1 ZG-2 ZG-3 ZG-4 ZG-1B ZG-2B ZG-3B ZG-4B ZG-1D ZG-2D ZG-3D ZG-4D
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 | Number697618018ZG001KK 06976180180013 | Date13 Apr 2023 | 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- Withdrawn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
- LED X-ray film viewer
- Model / Reference
- ZG-1 ZG-2 ZG-3 ZG-4 ZG-1B ZG-2B ZG-3B ZG-4B ZG-1D ZG-2D ZG-3D ZG-4D
- Primary DI / UDI-DI
- 06976180180013
- Basic UDI-DI
- 697618018ZG001KK
- EMDN Code
- Z110703 X–ray film viewer
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000034224
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Hunan Mplent Optoelectronics 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