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SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-RT062ZModel 5 tests/kitRef HWTS-RT062HModel 1 test/kit (Nasopharyngeal swab)
Identity
- Trade Name
- SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva EUDAMEDSARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) EUDAMED
- Device Name
- SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva EUDAMEDSARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) EUDAMED
- Model / Reference
- 5 tests/kit EUDAMEDHWTS-RT062Z EUDAMED1 test/kit (Nasopharyngeal swab) EUDAMEDHWTS-RT062H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366495 EUDAMED06974849366129 EUDAMED
- Basic UDI-DI
- B-06974849366495 EUDAMEDB-06974849366129 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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 Virus Antigen Detection Kit (colloidal gold method)-Saliva by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974849366495 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000012807
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 7c7b3846-254b-479d-a475-636e63e7c5ba 61 fields · synced Jul 27, 2026
- EUDAMED 18d3c8d1-baab-4925-83bb-230d64c95a74 61 fields · synced May 11, 2026