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Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fl…
EUDAMEDClass B (EU MDR)
Ref HWTS-RT176DModel HWTS-RT176A
Identity
- Trade Name
- Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR) EUDAMED
- Device Name
- Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR) EUDAMED
- Model / Reference
- HWTS-RT176A EUDAMEDHWTS-RT176D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849369625 EUDAMED
- Basic UDI-DI
- 697484936W01050405V2 EUDAMED
- EMDN Code
- W0105040504 INFLUENZA & PARA INFLUENZA - NA REAGENTS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
New Device
Yes
EUDAMED
Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fl… by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class B — IVDR — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697484936W01050405V2 | Class B | 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 00e8a34a-40d7-4c3e-b630-62da1f1728be 61 fields · synced Jul 21, 2026