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Tigsun COVID-19 Antigen Rapid Test
EUDAMEDClass A (EU MDR)
Ref Ref. DR1416S001Model 1 Test ,5 Tests,25 Tests
Identity
- Device Name
- Tigsun COVID-19 Antigen Rapid Test EUDAMED
- Model / Reference
- 1 Test ,5 Tests,25 Tests EUDAMEDRef. DR1416S001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642383098 EUDAMED
- Basic UDI-DI
- 6973642381416S5N EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class A 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
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Tigsun COVID-19 Antigen Rapid Test by Beijing Tigsun Diagnostics Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6973642381416S5N | Class A | 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 (1)
- EUDAMED 2e80a53c-6b08-4976-aed9-c63ad00746b4 61 fields · synced Jun 19, 2026