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SARS-CoV-2 IgM/IgG Antibody Detection Kit (Colloidal gold method)
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-RT090AModel 1 test/kitRef HWTS-RT090BModel 20 tests/kit
Identity
- Trade Name
- SARS-CoV-2 IgM/IgG Antibody Detection Kit (Colloidal gold method) EUDAMED
- Device Name
- SARS-CoV-2 IgM/IgG Antibody Detection Kit (Colloidal gold method) EUDAMED
- Model / Reference
- 1 test/kit EUDAMEDHWTS-RT090A EUDAMED20 tests/kit EUDAMEDHWTS-RT090B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366303 EUDAMED06974849366310 EUDAMED
- Basic UDI-DI
- B-06974849366303 EUDAMEDB-06974849366310 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 IgM/IgG Antibody Detection Kit (Colloidal gold method) 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-06974849366303 | 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 7774c71d-529f-413f-bba4-f87120220257 61 fields · synced Aug 2, 2026
- EUDAMED 2fa6af5a-2067-4a37-b7f9-f3d1a94e1f90 61 fields · synced May 18, 2026