Galactose Test Kit (Enzyme Chemical Reaction Method)
by Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd. China EUDAMED
Ref 1 test/box EMDN W01010212
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06975808410129 | Date24 Sep 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Galactose Test Kit (Enzyme Chemical Reaction Method)
- Model / Reference
- 1 test/box
- Primary DI / UDI-DI
- 06975808410129
- Basic UDI-DI
- B-06975808410129
- EMDN Code
- W01010212 Galactose
- Device Class
- Class IVD General
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000044320
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 684afed4-dd09-4daf-81b4-be2b31f9858a