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Tigsun COVID-19 Saliva Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 100 testsModel 50 testsModel 5 testsModel 20 testsModel 25 testsModel 10 tests
Identity
- Device Name
- Tigsun COVID-19 Saliva Antigen Rapid Test EUDAMED
- Model / Reference
- 100 tests EUDAMEDN/A EUDAMED50 tests EUDAMED5 tests EUDAMED20 tests EUDAMED25 tests EUDAMED10 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642382374 EUDAMED06973642382350 EUDAMED06973642382305 EUDAMED06973642382329 EUDAMED06973642382336 EUDAMED06973642382312 EUDAMED
- Basic UDI-DI
- B-06973642382374 EUDAMEDB-06973642382350 EUDAMEDB-06973642382305 EUDAMEDB-06973642382329 EUDAMEDB-06973642382336 EUDAMEDB-06973642382312 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 Saliva Antigen Rapid 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-06973642382374 | 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 (6)
- EUDAMED c74dc9db-71c4-46e0-8a13-528ac5275ee1 61 fields · synced Jul 31, 2026
- EUDAMED 3b8ba74f-a21d-46e6-b706-20b7cb58978a 61 fields · synced May 18, 2026
- EUDAMED 20be1f83-4a40-4eff-a188-d702a983fe3c 61 fields · synced May 18, 2026
- EUDAMED b87acba7-a0e7-4063-ab1e-e47bd3f49a98 61 fields · synced May 18, 2026
- EUDAMED afeb9e7e-f35f-42fc-b169-40ac3a304004 61 fields · synced May 18, 2026
- EUDAMED 13e0ed66-830d-4e28-8d6a-7421202d3cba 61 fields · synced May 18, 2026