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Tigsun VVC/TV/GV Combo Antigen Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 1 testModel 5 testsModel 10 testsModel 40 testsModel 25 tests
Identity
- Device Name
- Tigsun VVC/TV/GV Combo Antigen Test EUDAMED
- Model / Reference
- 1 test EUDAMEDN/A EUDAMED5 tests EUDAMED10 tests EUDAMED40 tests EUDAMED25 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642381032 EUDAMED06973642381049 EUDAMED06973642381056 EUDAMED06973642381087 EUDAMED06973642381070 EUDAMED
- Basic UDI-DI
- B-06973642381032 EUDAMEDB-06973642381049 EUDAMEDB-06973642381056 EUDAMEDB-06973642381087 EUDAMEDB-06973642381070 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 VVC/TV/GV Combo Antigen Test 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-06973642381032 | 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 5ad1a98f-9da1-4d8a-a1a9-a5517d1e02bd 61 fields · synced Sep 17, 2026
- EUDAMED cbfa3718-24e3-4fa1-8c8f-333591274dc2 61 fields · synced May 17, 2026
- EUDAMED e461db93-8cbd-4967-90db-43573543edb8 61 fields · synced May 18, 2026
- EUDAMED 066d8ae1-ee74-4453-a024-03eb9c17ffe0 61 fields · synced May 18, 2026
- EUDAMED 1d99dd5b-8073-45b3-a770-f12b7f18d01a 61 fields · synced May 18, 2026