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Tigsun COVID-19 Neutralizing Antibody Rapid Test(Total Antibody)
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 1 testModel 100 testsModel 5 testsModel 40 tests
Identity
- Device Name
- Tigsun COVID-19 Neutralizing Antibody Rapid Test(Total Antibody) EUDAMED
- Model / Reference
- 1 test EUDAMEDN/A EUDAMED100 tests EUDAMED5 tests EUDAMED40 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642382909 EUDAMED06973642382985 EUDAMED06973642382916 EUDAMED06973642382954 EUDAMED
- Basic UDI-DI
- B-06973642382909 EUDAMEDB-06973642382985 EUDAMEDB-06973642382916 EUDAMEDB-06973642382954 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(Total Antibody) 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-06973642382909 | 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 (4)
- EUDAMED 3561b531-d994-4e09-b811-f70a1085fa1a 61 fields · synced Sep 17, 2026
- EUDAMED 6da4d7fd-001c-4cfd-99fa-c1729fafba71 61 fields · synced May 17, 2026
- EUDAMED 9c21b543-d3b4-4fe7-aa80-61e9ac534c66 61 fields · synced May 18, 2026
- EUDAMED 94898a03-016d-45ef-b189-f7500d931d9c 61 fields · synced May 18, 2026