Fluorescence Immunoassay Analyzer
by Institute for Animal Health, Henan Academy of Agricultural Sciences EUDAMED
Active
Ref RDR-1000-001Model CHFF1000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number698036627CHFF1000E2L | Date19 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- CHFF1000, RDR-1000-001
- Primary DI / UDI-DI
- 06980366271006
- Basic UDI-DI
- 698036627CHFF1000E2L
- Direct Marketing DI
- 06980366271006
- EMDN Code
- W0201069099 Various rapid test chemistry / immunochemistry instruments - other
- Device Class
- Class A
- Market of Registration
- Finland
Manufacturer details
- EUDAMED SRN
- CN-MF-000059017
- Authorised representative
- Medunion S.L. ES-AR-000019366
Other devices from Institute for Animal Health, Henan Academy of Agricultural Sciences
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No