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Tigsun sFIt-1 Antigen Rapid Test (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 5 testsModel 50 testsModel 80 testsModel 10 testsModel 20 testsModel 40 tests
Identity
- Device Name
- Tigsun sFIt-1 Antigen Rapid Test (FIA) EUDAMED
- Model / Reference
- 5 tests EUDAMEDN/A EUDAMED50 tests EUDAMED80 tests EUDAMED10 tests EUDAMED20 tests EUDAMED40 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642381407 EUDAMED06973642381452 EUDAMED06973642381469 EUDAMED06973642381414 EUDAMED06973642381421 EUDAMED06973642381445 EUDAMED
- Basic UDI-DI
- B-06973642381407 EUDAMEDB-06973642381452 EUDAMEDB-06973642381469 EUDAMEDB-06973642381414 EUDAMEDB-06973642381421 EUDAMEDB-06973642381445 EUDAMED
- EMDN Code
- W0102050212 SOLUBLE FMS-LIKE TYROSINE KINASE-1 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 sFIt-1 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-06973642381407 | 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 e5bc9501-6125-4cea-bce1-91818bd19862 61 fields · synced Jul 26, 2026
- EUDAMED dd56e2b7-518d-4ea5-9d35-10217368565b 61 fields · synced May 16, 2026
- EUDAMED f0e835e2-a12a-42fe-9e06-d9ec79869767 61 fields · synced May 17, 2026
- EUDAMED f3f60585-a482-4bcd-8959-89f98cc02aa3 61 fields · synced May 17, 2026
- EUDAMED 058c3853-716b-4c6e-b1fb-eed6244e1380 61 fields · synced May 18, 2026
- EUDAMED 4276e594-a4b7-4370-bb90-bafdc51a0d52 61 fields · synced May 19, 2026