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Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 100 testsModel 25 testsModel 20 tests
Identity
- Device Name
- Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test EUDAMED
- Model / Reference
- 100 tests EUDAMEDN/A EUDAMED25 tests EUDAMED20 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642381292 EUDAMED06973642381254 EUDAMED06973642381247 EUDAMED
- Basic UDI-DI
- B-06973642381292 EUDAMEDB-06973642381254 EUDAMEDB-06973642381247 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT 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 Flu/RSV/AdV/PIV Combo 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-06973642381292 | 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 (3)
- EUDAMED 552b786c-64ba-4b9e-9f3b-943eb70ea5b5 61 fields · synced Aug 1, 2026
- EUDAMED 493fd987-1f95-4ce9-8416-c5c0d88cd658 61 fields · synced May 18, 2026
- EUDAMED 13effc1e-97eb-4861-8e1e-71be295cee22 61 fields · synced May 18, 2026