Anti-HAV Control
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-045982-00, 105-045981-00Model 105-038862-00, 105-038863-00, 105-045982-00, 105-045981-00, 105-045980-00, 105-045979-00 EMDN W0105080802
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB74000405G | Date11 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Antibody to Hepatitis A Virus (CLIA), Anti-HAV Control
- Model / Reference
- 105-038862-00, 105-038863-00, 105-045982-00, 105-045981-00, 105-045980-00, 105-045979-00
- Primary DI / UDI-DI
- 06903053074896, 06903053074841
- Basic UDI-DI
- 69449040AB74000405G
- Direct Marketing DI
- 0690305307489606903053074841
- EMDN Code
- W0105080802 Hepatitis virus controls - inf.imm.
- 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 & 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 (2)
- EUDAMED 11a2138d-be44-4748-aa7d-8d61a5e607c0
- EUDAMED 06903053074841|69449040AB74000405G