Hemolysis Solution
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-007856-00
EMDN W0103010299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040XQSJ-003Xhemo**HV | Date26 Apr 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Hemoglobin A1c Reagent
- Model / Reference
- 105-007856-00
- Primary DI / UDI-DI
- 06944904054025
- Basic UDI-DI
- 69449040XQSJ-003Xhemo**HV
- EMDN Code
- W0103010299 Other haemoglobin (types) testing - other
- 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 3b8a6710-c67a-407f-af29-00c79099dff7