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Tigsun TORCH lgM Rapid Test
EUDAMEDClass A (EU MDR)
Ref N/AModel 1 Test ,5 Tests,10 Tests,20 Tests,25 Tests,40 Tests,50 Tests,80 Tests,100 Tests
Identity
- Device Name
- Tigsun TORCH lgM Rapid Test EUDAMED
- Model / Reference
- 1 Test ,5 Tests,10 Tests,20 Tests,25 Tests,40 Tests,50 Tests,80 Tests,100 Tests EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642381841 EUDAMED
- Basic UDI-DI
- 6973642381402BD 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
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Tigsun TORCH lgM 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 | 6973642381402BD | 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 (2)
- EUDAMED 871b3db9-9fa7-4bab-bc40-e291260e74d5 61 fields · synced Aug 4, 2026
- EUDAMED 871b3db9-9fa7-4bab-bc40-e291260e74d5-1 61 fields · synced Jun 10, 2026