Hematology Analyzer Fluorescent Platelets Control
by Maccura Biotechnology Co., Ltd. China EUDAMED
Ref EBL2216101, EBL2209101, EBL2210101, EBL2202101, EBL2207101, EBL2204101, EBL2201101, EBL2211101, EBL2212101
EMDN W0103010505
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-EBL22161018U | Date25 May 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Hematology Analyzer Fluorescent Platelets Control
- Model / Reference
- EBL2216101, EBL2209101, EBL2210101, EBL2202101, EBL2207101, EBL2204101, EBL2201101, EBL2211101, EBL2212101
- Primary DI / UDI-DI
- D-EBL22161018U, D-EBL220910196, D-EBL22101017J, D-EBL22021017M, D-EBL22071018Q, D-EBL220410183, D-EBL22011017E, D-EBL22111017R, D-EBL22121017Y
- Basic UDI-DI
- B-EBL22161018U, B-EBL220910196, B-EBL22101017J, B-EBL22021017M, B-EBL22071018Q, B-EBL220410183, B-EBL22011017E, B-EBL22111017R, B-EBL22121017Y
- EMDN Code
- W0103010505 Platelet controls
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014618
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Maccura Biotechnology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (9)
- EUDAMED ed84ca4a-fb9f-43da-a16d-89426c95c258
- EUDAMED D-EBL220910196|B-EBL220910196
- EUDAMED D-EBL22101017J|B-EBL22101017J
- EUDAMED D-EBL22021017M|B-EBL22021017M
- EUDAMED D-EBL22071018Q|B-EBL22071018Q
- EUDAMED D-EBL220410183|B-EBL220410183
- EUDAMED D-EBL22011017E|B-EBL22011017E
- EUDAMED D-EBL22111017R|B-EBL22111017R
- EUDAMED D-EBL22121017Y|B-EBL22121017Y