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SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method)
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-RT062DModel 1 test/kit (Rachenabstrichen)Ref HWTS-RT062EModel 10 tests/kitRef HWTS-RT062HModel 1 test/kit (Nasal Swab)
Identity
- Trade Name
- SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) EUDAMEDSARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva EUDAMED
- Device Name
- SARS-CoV-2 Virus Antigen Detection Kit (Colloidal gold method) EUDAMEDSARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva EUDAMED
- Model / Reference
- 1 test/kit (Rachenabstrichen) EUDAMEDHWTS-RT062D EUDAMED10 tests/kit EUDAMEDHWTS-RT062E EUDAMED1 test/kit (Nasal Swab) EUDAMEDHWTS-RT062H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366105 EUDAMED06974849366501 EUDAMED06974849366112 EUDAMED
- Basic UDI-DI
- B-06974849366105 EUDAMEDB-06974849366501 EUDAMEDB-06974849366112 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) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06974849366105 | 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 (3)
- EUDAMED 00633181-074b-487a-ae23-bdf320e25147 61 fields · synced Aug 3, 2026
- EUDAMED 8098a0ed-ff78-42ea-9279-9e9d1fca67ca 61 fields · synced May 16, 2026
- EUDAMED dda132d9-882b-4cb4-b449-4dc58d5bd309 61 fields · synced May 18, 2026