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Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Spike RBD Antibody
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-RT055AModel 96 tests/kit
Identity
- Trade Name
- Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Spike RBD Antibody EUDAMED
- Device Name
- Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Spike RBD Antibody EUDAMED
- Model / Reference
- 96 tests/kit EUDAMEDHWTS-RT055A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366143 EUDAMED
- Basic UDI-DI
- B-06974849366143 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Enzyme-Linked Immunosorbent Assay for detecting SARS-CoV-2 Spike RBD Antibody by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD…
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-06974849366143 | 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 (1)
- EUDAMED 7e304f5d-602f-4c56-ba2f-5bb4178bd02d 61 fields · synced Jun 19, 2026