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Tigsun CT/NG/MG Combo Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 100 testsModel 10 testsModel 1 testModel 5 testsModel 50 testsModel 80 tests
Identity
- Device Name
- Tigsun CT/NG/MG Combo Antigen Rapid Test EUDAMED
- Model / Reference
- 100 tests EUDAMEDN/A EUDAMED10 tests EUDAMED1 test EUDAMED5 tests EUDAMED50 tests EUDAMED80 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642381209 EUDAMED06973642381148 EUDAMED06973642381124 EUDAMED06973642381131 EUDAMED06973642381186 EUDAMED06973642381193 EUDAMED
- Basic UDI-DI
- B-06973642381209 EUDAMEDB-06973642381148 EUDAMEDB-06973642381124 EUDAMEDB-06973642381131 EUDAMEDB-06973642381186 EUDAMEDB-06973642381193 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 CT/NG/MG Combo Antigen Rapid 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-06973642381209 | 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 e6f92b93-687c-40a2-aa4b-968a4d994ac8 61 fields · synced Sep 17, 2026
- EUDAMED d12b9cb7-f3fe-4197-a2b6-5edf395a96aa 61 fields · synced May 17, 2026
- EUDAMED 2321b352-255c-44f4-88f3-04b8b2479978 61 fields · synced May 17, 2026
- EUDAMED 7fea2b2d-63ca-4718-99a1-4c9a5bf5ee6a 61 fields · synced May 17, 2026
- EUDAMED 440ba481-c604-4e89-951f-c58cc1e1cb60 61 fields · synced May 17, 2026
- EUDAMED 1f511ab1-bed6-4790-a4a8-4fbb64ddeeed 61 fields · synced May 18, 2026