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Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (E…
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-UR010AModel 50 tests/kitRef HWTS-EV015ARef HWTS-RT102ARef HWTS-FG005ARef HWTS-RT056AModel 16 tests/kitRef HWTS-RT049A
Identity
- Trade Name
- Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus EUDAMEDNucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Enterovirus EUDAMEDNucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Mycobacterium tuberculosis EUDAMEDNucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Candida Albicans EUDAMEDNucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Novel Coronavirus (SARS-CoV-2) EUDAMEDNucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Influenza A virus EUDAMED
- Device Name
- Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus EUDAMEDNucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Enterovirus EUDAMEDNucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Mycobacterium tuberculosis EUDAMEDNucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Candida Albicans EUDAMEDNucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Novel Coronavirus (SARS-CoV-2) EUDAMEDNucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Influenza A virus EUDAMED
- Model / Reference
- 50 tests/kit EUDAMEDHWTS-UR010A EUDAMEDHWTS-EV015A EUDAMEDHWTS-RT102A EUDAMEDHWTS-FG005A EUDAMED16 tests/kit EUDAMEDHWTS-RT056A EUDAMEDHWTS-RT049A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366211 EUDAMED06974849366006 EUDAMED06974849366365 EUDAMED06974849366204 EUDAMED06974849366150 EUDAMED06974849366020 EUDAMED
- Basic UDI-DI
- B-06974849366211 EUDAMEDB-06974849366006 EUDAMEDB-06974849366365 EUDAMEDB-06974849366204 EUDAMEDB-06974849366150 EUDAMEDB-06974849366020 EUDAMED
- EMDN Code
- W0105011199 STREPTOCOCCAL REAGENTS - OTHER EUDAMEDW0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMEDW0105010799 MYCOBACTERIA REAGENTS - OTHER EUDAMEDW0105060302 CANDIDA ALBICANS 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
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (E… 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-06974849366211 | 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 (6)
- EUDAMED 67d3af07-bfb4-4826-b5db-500824e0978d 61 fields · synced Jul 22, 2026
- EUDAMED 1ef687d2-8702-48ee-9405-619998647ed8 61 fields · synced May 17, 2026
- EUDAMED 3346547b-a4db-446d-84c0-0892d19631e2 61 fields · synced May 17, 2026
- EUDAMED d4926c7a-8c9a-40be-bb9a-0425e3638195 61 fields · synced May 17, 2026
- EUDAMED 1f26936f-9206-4b01-9cff-370f6c395275 61 fields · synced May 18, 2026
- EUDAMED 9f9f5e62-d292-425d-a714-679dd037f19f 61 fields · synced May 18, 2026