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Tigsun COVID-19 Antigen Rapid Test (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 1 testModel 50 testsModel 80 testsModel 100 testsModel 25 testsModel 5 testsModel 10 tests
Identity
- Device Name
- Tigsun COVID-19 Antigen Rapid Test (FIA) EUDAMED
- Model / Reference
- 1 test EUDAMEDN/A EUDAMED50 tests EUDAMED80 tests EUDAMED100 tests EUDAMED25 tests EUDAMED5 tests EUDAMED10 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642382114 EUDAMED06973642382176 EUDAMED06973642382183 EUDAMED06973642382190 EUDAMED06973642382152 EUDAMED06973642382121 EUDAMED06973642382138 EUDAMED
- Basic UDI-DI
- B-06973642382114 EUDAMEDB-06973642382176 EUDAMEDB-06973642382183 EUDAMEDB-06973642382190 EUDAMEDB-06973642382152 EUDAMEDB-06973642382121 EUDAMEDB-06973642382138 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - 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 COVID-19 Antigen Rapid Test (FIA) 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-06973642382114 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Tigsun Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000034480
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (7)
- EUDAMED 28cdb922-41f2-4c3d-abae-6766ea3288c1 61 fields · synced Sep 18, 2026
- EUDAMED 9882ebb8-878c-4de4-a80a-7c6c3e27cc35 61 fields · synced May 18, 2026
- EUDAMED 6ba1d983-8356-4a21-a99f-9409123433cf 61 fields · synced May 18, 2026
- EUDAMED 71d3dae6-07b2-41a4-b0f5-0ef542a8510d 61 fields · synced May 18, 2026
- EUDAMED a1e9fc4b-cf37-4a6a-a503-eb83aae0f8bc 61 fields · synced May 18, 2026
- EUDAMED 0c102999-af50-4691-b937-57a92bf3f2b5 61 fields · synced May 19, 2026
- EUDAMED e85d59e0-d584-4802-9c6f-3e3b9dceae66 61 fields · synced May 19, 2026