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Tigsun Adeno/Rota/Noro Virus Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 80 testsModel 20 testsModel 10 testsModel 100 testsModel 50 tests
Identity
- Device Name
- Tigsun Adeno/Rota/Noro Virus Antigen Rapid Test EUDAMED
- Model / Reference
- 80 tests EUDAMEDN/A EUDAMED20 tests EUDAMED10 tests EUDAMED100 tests EUDAMED50 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642381827 EUDAMED06973642381780 EUDAMED06973642381773 EUDAMED06973642381834 EUDAMED06973642381810 EUDAMED
- Basic UDI-DI
- B-06973642381827 EUDAMEDB-06973642381780 EUDAMEDB-06973642381773 EUDAMEDB-06973642381834 EUDAMEDB-06973642381810 EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS 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 Adeno/Rota/Noro Virus Antigen 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-06973642381827 | 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 626330ce-0a9a-4060-b6b6-ed50d6ae448d 61 fields · synced Jul 25, 2026
- EUDAMED 2c27796c-51e2-4979-bd78-96459a6edf75 61 fields · synced May 16, 2026
- EUDAMED bfb89a48-f340-4590-b53f-00c88360804f 61 fields · synced May 17, 2026
- EUDAMED f18b4a32-0fef-43a2-9b0d-f22c14ca62f5 61 fields · synced May 17, 2026
- EUDAMED 61622f31-5692-4f0a-93cb-c661987c6d6e 61 fields · synced May 18, 2026