Anti-A+B Monoclonal
by Spinreact S.A.U. Spain EUDAMED
Ref 1700006 , 1700006
EMDN W0103030102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberV76 129992 0003 | Date11 Sep 2026 | StatusActive |
| European Union | CE/IVDD | Number8431673GSTF01XG | Date14 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Certificates
- V76 129992 0003 Issued
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 11 Sep 2026
- Expires
- 10 Sep 2031
Specification
- Device Name
- Blood grouping
- Model / Reference
- 1700006
- Primary DI / UDI-DI
- 08431673700065
- Basic UDI-DI
- 8431673GSTF01XG, B-08431673700065
- Direct Marketing DI
- 08431673700065
- EMDN Code
- W0103030102 Abo sera
- Device Class
- Class DClass IVD Annex II List A
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000011023
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED 7f19181f-24c3-4c9f-9b80-06c466643db1
- EUDAMED 08431673700065|B-08431673700065