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Tigsun TORCH lgM/lgG 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/lgG 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
- 06973642381995 EUDAMED
- Basic UDI-DI
- 6973642381401BB 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/lgG 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 | 6973642381401BB | 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 579ddf38-b66b-4e89-bf98-66c18a03de13 61 fields · synced Jul 24, 2026
- EUDAMED 579ddf38-b66b-4e89-bf98-66c18a03de13-1 61 fields · synced Jun 10, 2026