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Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection…
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-RT060EModel 48 tests/kitRef ACAB04D-BHG48E
Identity
- Trade Name
- Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)-Subpackage EUDAMED
- Device Name
- Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)-Subpackage EUDAMEDSARS-CoV-2 & Influenza A/B Detection Kit (Fluorescence PCR) EUDAMED
- Model / Reference
- 48 tests/kit EUDAMEDHWTS-RT060E EUDAMEDACAB04D-BHG48E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366433 EUDAMEDD-81649002ACAB04D5RDF EUDAMED
- Basic UDI-DI
- B-06974849366433 EUDAMEDB-81649002ACAB04D5RDF EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMEDW0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMEDGermany 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
Freeze-dried SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Combined Detection… 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-06974849366433 | 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 cad8115e-efb1-4de7-a949-a6cf5121e188 61 fields · synced Oct 6, 2026
- EUDAMED 16648e7f-38eb-468f-ae5c-d6c1e4e77eaf 61 fields · synced Jul 10, 2026