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SARS-CoV-2 Antigen Test
EUDAMEDClass IVD General (EU MDR)
Ref SCAg-1，SCAg-5， SCAg-25，SCAg02-1，SCAg02-5，SCAg02-25
Identity
- Trade Name
- SARS-CoV-2 Antigen Test EUDAMED
- Model / Reference
- SCAg-1，SCAg-5， SCAg-25，SCAg02-1，SCAg02-5，SCAg02-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626285 EUDAMED
- Basic UDI-DI
- B-06974689626285 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 Antigen Test by TargetingOne Technology (Beijing) Corporation — 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-06974689626285 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 951a08c4-a025-442e-83c9-66d0351e55fb 61 fields · synced Jun 18, 2026