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Tigsun COVID-19 Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 80 testsRef Ref. DR1416S005Model 1 Test ,5 Tests,25 TestsRef Ref. DR1416S025Model 25 testsModel 10 testsModel 50 tests
Identity
- Device Name
- Tigsun COVID-19 Antigen Rapid Test EUDAMED
- Model / Reference
- 80 tests EUDAMEDN/A EUDAMED1 Test ,5 Tests,25 Tests EUDAMEDRef. DR1416S005 EUDAMEDRef. DR1416S025 EUDAMED25 tests EUDAMED10 tests EUDAMED50 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642382275 EUDAMED06973642383081 EUDAMED06973642383104 EUDAMED06973642382244 EUDAMED06973642382220 EUDAMED06973642382268 EUDAMED
- Basic UDI-DI
- B-06973642382275 EUDAMED6973642381416S5N EUDAMEDB-06973642382244 EUDAMEDB-06973642382220 EUDAMEDB-06973642382268 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A 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
EUDAMEDEUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Tigsun COVID-19 Antigen Rapid Test by Beijing Tigsun Diagnostics Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06973642382275 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06973642382275 | 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 e18673bb-8a40-4c89-9e12-aecb9c4b7911 61 fields · synced Sep 18, 2026
- EUDAMED 9b0a033e-c76e-4131-9322-5f0ceeba027a 61 fields · synced May 17, 2026
- EUDAMED 26501f7a-14ec-488d-becd-6991bb5aae9c 61 fields · synced May 17, 2026
- EUDAMED 7e3644a1-e901-42e4-9840-4e285cd2cc74 61 fields · synced May 17, 2026
- EUDAMED 89bacea1-da05-4aae-be58-b59e97e84e44 61 fields · synced May 18, 2026
- EUDAMED 7854d984-8852-48aa-8d7c-3d795abe0798 61 fields · synced May 18, 2026