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Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-RT057GModel 50 tests/kitRef HWTS-RT057FModel 48 tests/kit
Identity
- Trade Name
- Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 EUDAMEDFreeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 -Subpackage EUDAMED
- Device Name
- Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 EUDAMEDFreeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 -Subpackage EUDAMED
- Model / Reference
- 50 tests/kit EUDAMEDHWTS-RT057G EUDAMED48 tests/kit EUDAMEDHWTS-RT057F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366402 EUDAMED06974849366419 EUDAMED
- Basic UDI-DI
- B-06974849366402 EUDAMEDB-06974849366419 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
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 Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974849366402 | 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 f270b678-72f0-438f-9182-a44015a458fb 61 fields · synced Jul 28, 2026
- EUDAMED 3419d962-c355-49da-9f92-7e186dc7b216 61 fields · synced May 18, 2026