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Tigsun COVID-19 Neutralizing Antibody Rapid Test(FIA)
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 5 testsModel 1 testModel 100 testsModel 80 testsModel 10 tests
Identity
- Device Name
- Tigsun COVID-19 Neutralizing Antibody Rapid Test(FIA) EUDAMED
- Model / Reference
- 5 tests EUDAMEDN/A EUDAMED1 test EUDAMED100 tests EUDAMED80 tests EUDAMED10 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642382756 EUDAMED06973642382749 EUDAMED06973642382824 EUDAMED06973642382817 EUDAMED06973642382763 EUDAMED
- Basic UDI-DI
- B-06973642382756 EUDAMEDB-06973642382749 EUDAMEDB-06973642382824 EUDAMEDB-06973642382817 EUDAMEDB-06973642382763 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 Neutralizing Antibody Rapid Test(FIA) 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-06973642382756 | 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 (5)
- EUDAMED ded1427d-dd89-4181-9e4e-d66c058b29b2 61 fields · synced Aug 3, 2026
- EUDAMED 807fa1e4-fce6-47a8-a8d8-a76646327138 61 fields · synced May 16, 2026
- EUDAMED b6e2fdde-d12c-4838-b103-14f7857a12ec 61 fields · synced May 18, 2026
- EUDAMED 0315414d-d201-461f-b47f-c23ae0c3d5a9 61 fields · synced May 18, 2026
- EUDAMED aea67550-1844-4001-b3cf-74c0f9af9630 61 fields · synced May 19, 2026