Medical Dry Imager
by Weifang Hengcai Digital Photo Materials Co., Ltd 3 variants
Ref HYC-4600, HYC-860Model HYC-4600,HYC-860,HYC-350,HYC-4000,HYC-5000,HYC-6000,HYC-7000,HYC-8000,HYC-9000,HYC-4300,HYC-4500,HYC-4800,HYC-5200,HYC-6200,HYC-8200,HYC-9200
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 | Number697555643MDI01MT | Date3 Jul 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- Withdrawn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
- Medical Dry Imager
- Model / Reference
- HYC-4600, HYC-860, HYC-350, HYC-4000, HYC-5000, HYC-6000, HYC-7000, HYC-8000, HYC-9000, HYC-4300, HYC-4500, HYC-4800, HYC-5200, HYC-6200, HYC-8200, HYC-9200
- Primary DI / UDI-DI
- 06975556430097, 06975556430103
- Basic UDI-DI
- 697555643MDI01MT
- Direct Marketing DI
- 06975556430097
- EMDN Code
- Z119099 Various bioimaging and radiotherapy instruments - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000027698
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Weifang Hengcai Digital Photo Materials Co., Ltd
See all devices from Weifang Hengcai Digital Photo Materials 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