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Nucleic Acid Detection Kit for Clostridium difficile toxin A/B gene
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-OT031AModel 50 tests/kitRef HWTS-EV032ARef HWTS-EV032B
Identity
- Trade Name
- Nucleic Acid Detection Kit for Clostridium difficile toxin A/B gene EUDAMEDNucleic Acid Detection Kit for Clostridium Difficile toxin A/B gene (Fluorescence PCR) EUDAMED
- Device Name
- Nucleic Acid Detection Kit for Clostridium difficile toxin A/B gene EUDAMEDNucleic Acid Detection Kit for Clostridium Difficile toxin A/B gene (Fluorescence PCR) EUDAMED
- Model / Reference
- 50 tests/kit EUDAMEDHWTS-OT031A EUDAMEDHWTS-EV032A EUDAMEDHWTS-EV032B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366198 EUDAMED06974849369694 EUDAMED
- Basic UDI-DI
- B-06974849366198 EUDAMED697484936HWTS-EV032AYS EUDAMED
- EMDN Code
- W0105011802 C.DIFFICILE TOXIN A/B DETECTION EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Spain EUDAMEDGermany 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
New Device
Yes
EUDAMED
Nucleic Acid Detection Kit for Clostridium difficile toxin A/B gene by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDR, IVDD — listed…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06974849366198 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06974849366198 | 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 5b870567-e4ce-454e-9565-184a56a95a81 61 fields · synced Jul 8, 2026
- EUDAMED 6d518050-2415-414c-901a-b6672d24a4d5 61 fields · synced Jun 19, 2026
- EUDAMED d5863cd9-8da3-4dbd-b0e3-65b6dcd1827b 61 fields · synced Jul 8, 2026