Carbohydrate Antigen 242(CLIA)
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. EUDAMED
Active
Ref 105-010099-00Model 105-010089-00、105-010099-00、105-010139-00
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040004V-CA242*****Y7 | Date15 Sep 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Carbohydrate Antigen 242(CLIA)、CA 242 Calibrators
- Model / Reference
- 105-010089-00、105-010099-00、105-010139-00, 105-010099-00
- Primary DI / UDI-DI
- 06936415908133
- Basic UDI-DI
- 69449040004V-CA242*****Y7
- EMDN Code
- W0102030108 Cancer antigen 242
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Show properties
Other properties (6)
- Sterile: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No