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SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluore…
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-RT060AModel 50 tests/kitRef ACAB04D-BOG48E
Identity
- Trade Name
- SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) EUDAMED
- Device Name
- SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) EUDAMEDSARS-CoV-2 & Influenza A/B Detection Kit (Fluorescence PCR) EUDAMED
- Model / Reference
- 50 tests/kit EUDAMEDHWTS-RT060A EUDAMEDACAB04D-BOG48E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366266 EUDAMEDD-69509960ACAB04DJXYT EUDAMED
- Basic UDI-DI
- B-06974849366266 EUDAMEDB-69509960ACAB04DJXYT EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMEDW0105090601 CORONAVIRUS / INFLUENZA - RT & POC 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
EUDAMEDEUDAMED
Microbial Substances
Yes
EUDAMEDEUDAMED
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/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluore… 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-06974849366266 | 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 344e1c99-1970-4214-b080-d8830687ee64 61 fields · synced Jul 25, 2026
- EUDAMED cacc2f1a-6815-4fed-9c0e-b379ff09dc22 61 fields · synced Jul 25, 2026