MR Buffer solution
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-036023-00Model 105-001688-00、105-001692-00、105-001693-00
EMDN W01019001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040BA80ISESOLUTIONZJ | Date11 May 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- MR Buffer Solution、MR Detergent Solution、MR Na/K Check Solution
- Model / Reference
- 105-001688-00、105-001692-00、105-001693-00, 105-036023-00
- Primary DI / UDI-DI
- 06903053039895
- Basic UDI-DI
- 69449040BA80ISESOLUTIONZJ
- EMDN Code
- W01019001 Buffers (unassignable), supplem. reagents, etc (cc)
- Device Class
- Class A
- 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 & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED f37cc9b3-6bf9-4299-a5d4-fe03515936d7