Herpes Simplex Virus-2 IgG（CLIA）
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-012506-00, 105-012507-00, 105-012509-00, 105-012510-00Model 105-012506-00 、105-012507-00、105-012509-00、105-012510-00 EMDN W0105040309
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB74000125B | Date19 Aug 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 105-012506-00 、105-012507-00、105-012509-00、105-012510-00, 105-012506-00, 105-012507-00, 105-012509-00, 105-012510-00
- Primary DI / UDI-DI
- 06903053039536, 06903053039666, 06903053039529, 06903053039598
- Basic UDI-DI
- 69449040AB74000125B
- EMDN Code
- W0105040309 Hsv 2 igg
- 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 (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (4)
- EUDAMED dc4e01f5-ab2a-4355-8cba-c3b24eaf7518
- EUDAMED 06903053039666|69449040AB74000125B
- EUDAMED 06903053039529|69449040AB74000125B
- EUDAMED 06903053039598|69449040AB74000125B