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Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathoge…
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-RT058AModel 50tests/kitRef HWTS-RT058EModel 25 tests/kitRef HWTS-RT058ZModel 48 tests/kit
Identity
- Trade Name
- Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens EUDAMED
- Device Name
- Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathogens EUDAMED
- Model / Reference
- 50tests/kit EUDAMEDHWTS-RT058A EUDAMED25 tests/kit EUDAMEDHWTS-RT058E EUDAMED48 tests/kit EUDAMEDHWTS-RT058Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366068 EUDAMED06974849366624 EUDAMED06974849366631 EUDAMED
- Basic UDI-DI
- B-06974849366068 EUDAMEDB-06974849366624 EUDAMEDB-06974849366631 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS 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
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
Real time fluorescent RT-PCR kit for detecting six kinds of respiratory pathoge… 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-06974849366068 | 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 (3)
- EUDAMED 1d58ccbc-77b8-4034-ac58-7c1c3186ba26 61 fields · synced Jul 15, 2026
- EUDAMED ef5bc88c-3d74-4b8c-a09a-7534b81d4892 61 fields · synced May 17, 2026
- EUDAMED 69c01b97-8988-4f60-9b76-7e957142223e 61 fields · synced May 17, 2026