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Tigsun COVID-19 Saliva Antigen Rapid Lollipop Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 40 testsModel 50 testsModel 10 testsModel 20 testsModel 80 tests
Identity
- Device Name
- Tigsun COVID-19 Saliva Antigen Rapid Lollipop Test EUDAMEDTigsun COVID-19 Saliva Antigen Rapid Test EUDAMED
- Model / Reference
- 40 tests EUDAMEDN/A EUDAMED50 tests EUDAMED10 tests EUDAMED20 tests EUDAMED80 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642382619 EUDAMED06973642382626 EUDAMED06973642382589 EUDAMED06973642382596 EUDAMED06973642382633 EUDAMED06973642382367 EUDAMED
- Basic UDI-DI
- B-06973642382619 EUDAMEDB-06973642382626 EUDAMEDB-06973642382589 EUDAMEDB-06973642382596 EUDAMEDB-06973642382633 EUDAMEDB-06973642382367 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 Lollipop Test by Beijing Tigsun Diagnostics Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06973642382619 | 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 9170c1c7-84ec-4ee4-a7e5-46d76385f7ed 61 fields · synced Sep 17, 2026
- EUDAMED 33380219-f3f1-4a06-ab3f-917220da3961 61 fields · synced May 17, 2026
- EUDAMED 8624762f-018b-4f21-bb18-0c51503753db 61 fields · synced May 17, 2026
- EUDAMED ac08ed31-8715-4989-8e1f-ff2daf005523 61 fields · synced May 18, 2026
- EUDAMED ea57630a-d390-449d-ba8a-f683e6175147 61 fields · synced May 18, 2026
- EUDAMED 64422b54-6b2b-4c32-9285-7ac673b828f3 61 fields · synced May 19, 2026