Innovita
by Innovita (Tangshan) Biological Technology Co., Ltd. China EUDAMED
Ref YF358C184, YF358C185, YF358C186Model YF358C184 (1 test/box), YF358C185 (2 tests/box), YF358C186 (5 tests/box) EMDN W0105099099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697064009YF358G4 | Date4 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IX 2006076-3 Issued
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 16 Jun 2026
- Expires
- 15 Jun 2031
Specification
- Device Name
- SARS-CoV-2 Antigen Rapid Test
- Model / Reference
- YF358C184 (1 test/box), YF358C185 (2 tests/box), YF358C186 (5 tests/box), YF358C184, YF358C185, YF358C186
- Primary DI / UDI-DI
- 06970640092724
- Basic UDI-DI
- 697064009YF358G4
- Direct Marketing DI
- 06970640092724
- EMDN Code
- W0105099099 Virology - rt & poc - other
- Device Class
- Class C
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000018424
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Innovita (Tangshan) Biological Technology Co., Ltd.
See all devices from Innovita (Tangshan) Biological Technology 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
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 06970640092724|697064009YF358G4