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Tigsun COVID-19 Combo lgM/lgG Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 40 testsModel 20 testsModel 80 testsModel 5 testsModel 10 testsModel 25 testsModel 50 testsModel 100tests
Identity
- Device Name
- Tigsun COVID-19 Combo lgM/lgG Rapid Test EUDAMED
- Model / Reference
- 40 tests EUDAMEDN/A EUDAMED20 tests EUDAMED80 tests EUDAMED5 tests EUDAMED10 tests EUDAMED25 tests EUDAMED50 tests EUDAMED100tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642382077 EUDAMED06973642382053 EUDAMED06973642382091 EUDAMED06973642382039 EUDAMED06973642382046 EUDAMED06973642382060 EUDAMED06973642382084 EUDAMED06973642382107 EUDAMED
- Basic UDI-DI
- B-06973642382077 EUDAMEDB-06973642382053 EUDAMEDB-06973642382091 EUDAMEDB-06973642382039 EUDAMEDB-06973642382046 EUDAMEDB-06973642382060 EUDAMEDB-06973642382084 EUDAMEDB-06973642382107 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 COVID-19 Combo lgM/lgG 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-06973642382077 | 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 (8)
- EUDAMED a4c2483d-b9c0-450b-9e05-597b6f4eb774 61 fields · synced Aug 3, 2026
- EUDAMED b95374eb-8faf-4274-b5b8-9a01da902f1a 61 fields · synced May 17, 2026
- EUDAMED 41541eb9-c95d-4d2b-8e80-640123593e33 61 fields · synced May 17, 2026
- EUDAMED 1c88212e-4834-479e-8109-d837e78731c0 61 fields · synced May 17, 2026
- EUDAMED 11481d2c-82ec-4904-ae72-affdbc5a5c34 61 fields · synced May 18, 2026
- EUDAMED 2c331b28-7135-49a5-b6f0-4be762465d55 61 fields · synced May 18, 2026
- EUDAMED 843da837-90b1-4148-94cb-890a56f1a139 61 fields · synced May 18, 2026
- EUDAMED 7853c595-645d-46a4-8a8b-30f4a1267dec 61 fields · synced May 19, 2026