Auto Chemistry Analyzer
by Rayto Life and Analytical Sciences Co., Ltd. 5 variants
Ref Chemray 380, Chemray 330, Chemray 120, Chemray 310Model Chemray 330
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69470244014725Y | Date24 Apr 2022 | 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- Withdrawn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/IVDR Active
Specification
- Model / Reference
- Chemray 380, Chemray 330, Chemray 120, Chemray 310
- Primary DI / UDI-DI
- 06947024409478, 06947024409461, 06947024409447, 06947024412829
- Basic UDI-DI
- 69470244014725Y, 694702440234967, 69470244022645W, 69470244023325N
- Direct Marketing DI
- 06947024409478069470244094610694702440944706947024412829
- EMDN Code
- W0201010102, W0201010101
- Device Class
- Class A
- Market of Registration
- IrelandGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011141
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Rayto Life and Analytical Sciences Co., Ltd.
See all devices from Rayto Life and Analytical Sciences Co., Ltd. →
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