Auto Chemistry Analyzer
by Rayto Life and Analytical Sciences Co., Ltd. 5 variants
Ref Chemray 240
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 | Number69470244023015B | 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- Withdrawn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 240
- Primary DI / UDI-DI
- 06947024409454
- Basic UDI-DI
- 69470244023015B
- Direct Marketing DI
- 06947024409454
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
- Device Class
- Class A
- Market of Registration
- Ireland
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