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Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 50 testsModel 25 testsModel 100 testsModel 10 testsModel 20 tests
Identity
- Device Name
- Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test EUDAMED
- Model / Reference
- 50 tests EUDAMEDN/A EUDAMED25 tests EUDAMED100 tests EUDAMED10 tests EUDAMED20 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642382534 EUDAMED06973642382510 EUDAMED06973642382558 EUDAMED06973642382497 EUDAMED06973642382503 EUDAMED
- Basic UDI-DI
- B-06973642382534 EUDAMEDB-06973642382510 EUDAMEDB-06973642382558 EUDAMEDB-06973642382497 EUDAMEDB-06973642382503 EUDAMED
- EMDN Code
- W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - 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 Flu A/B, RSV, COVID-19 Ag Combo 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-06973642382534 | 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 51d9a371-4d9d-4d29-80fc-57a47c07f5c8 61 fields · synced Sep 18, 2026
- EUDAMED e672219b-f698-4291-9b8c-5fc5a33e5cd0 61 fields · synced May 17, 2026
- EUDAMED 420737a8-7bb0-41c1-95e4-25d591e724e7 61 fields · synced May 17, 2026
- EUDAMED 0cad0f26-dfa8-4f20-b2f6-48f229272c4c 61 fields · synced May 18, 2026
- EUDAMED 2ad97d08-708f-4230-a847-d6e0ea84fb90 61 fields · synced May 18, 2026