← Back to catalogue
Tigsun Flu A/B, COVID-19 Ag Combo Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 10 testsModel 25 testsModel 50 testsModel 5 testsModel 20 tests
Identity
- Device Name
- Tigsun Flu A/B, COVID-19 Ag Combo Test EUDAMED
- Model / Reference
- 10 tests EUDAMEDN/A EUDAMED25 tests EUDAMED50 tests EUDAMED5 tests EUDAMED20 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642382404 EUDAMED06973642382428 EUDAMED06973642382442 EUDAMED06973642382398 EUDAMED06973642382411 EUDAMED
- Basic UDI-DI
- B-06973642382404 EUDAMEDB-06973642382428 EUDAMEDB-06973642382442 EUDAMEDB-06973642382398 EUDAMEDB-06973642382411 EUDAMED
- EMDN Code
- W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Tigsun Flu A/B, COVID-19 Ag Combo Test by Beijing Tigsun Diagnostics Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06973642382404 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Tigsun Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000034480
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (5)
- EUDAMED 38fa7baa-a7bf-4fd1-9289-d8dd6cb4064b 61 fields · synced Jul 23, 2026
- EUDAMED aad25e6d-0b76-4ada-8a93-888eb3329942 61 fields · synced May 17, 2026
- EUDAMED f30c1103-c1fc-46ba-9b15-e1da3a38c0ad 61 fields · synced May 17, 2026
- EUDAMED 8b01b1b9-1e89-4e3e-a7b8-bc328fec55d7 61 fields · synced May 18, 2026
- EUDAMED fc5db0c2-cfa1-4f18-ad15-570acc23ac06 61 fields · synced May 18, 2026