HBsAg Positive Control
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. United States EUDAMED
Ref 1002213Model HBsAg121, HBsAg122
EMDN W0105080802
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberV76 044751 0357 | Date14 Oct 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
EU market availability
Available in 2 countries, as listed in EUDAMED:
- Germanysince 1 Jan 2027
- Netherlandssince 1 Jan 2027
Certificates
- V76 044751 0357 Issued
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 14 Oct 2026
- Expires
- 13 Oct 2031
Specification
- Device Name
- Hepatitis B Surface Antigen (CLIA)
- Model / Reference
- HBsAg121, HBsAg122, 1002213
- Primary DI / UDI-DI
- 06903053106559
- Basic UDI-DI
- 69449040AB74000315F
- EMDN Code
- W0105080802 Hepatitis virus controls - inf.imm.
- Device Class
- Class D
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Mindray Bio-Medical Electronics Co., LTD
See all devices from Shenzhen Mindray Bio-Medical Electronics Co., LTD →
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 06903053106559|69449040AB74000315F