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Tigsun COVID-19 Neutralizing Antibody Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 80 testsModel 100 testsModel 25 testsModel 10 testsModel 40 tests
Identity
- Device Name
- Tigsun COVID-19 Neutralizing Antibody Rapid Test EUDAMEDTigsun COVID-19 Neutralizing Antibody Rapid Test(lgG) EUDAMED
- Model / Reference
- 80 tests EUDAMEDN/A EUDAMED100 tests EUDAMED25 tests EUDAMED10 tests EUDAMED40 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642382725 EUDAMED06973642382732 EUDAMED06973642383036 EUDAMED06973642383074 EUDAMED06973642382671 EUDAMED06973642383043 EUDAMED
- Basic UDI-DI
- B-06973642382725 EUDAMEDB-06973642382732 EUDAMEDB-06973642383036 EUDAMEDB-06973642383074 EUDAMEDB-06973642382671 EUDAMEDB-06973642383043 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 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-06973642382725 | 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 df433f83-6ec4-4bfb-b2a4-442aa62a4e6f 61 fields · synced Aug 4, 2026
- EUDAMED e796d9e3-a5d6-461b-a758-e12357d26007 61 fields · synced May 16, 2026
- EUDAMED 75604792-aac7-4245-9e4c-dea2e7d70b90 61 fields · synced May 17, 2026
- EUDAMED 64dc2383-b816-441e-b805-0a750b9bf884 61 fields · synced May 17, 2026
- EUDAMED 941651f7-f794-4c00-b20d-fef784b4a81b 61 fields · synced May 18, 2026
- EUDAMED 8d8ec1f2-b8ef-4de9-9ced-d04e2803a861 61 fields · synced May 18, 2026