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Clostridium Difficile TcdA Gene And TcdB Gene Nucleic Acid Test Kit (Fluorescen…
EUDAMEDClass IVD General (EU MDR)
Ref B28201T2048
Identity
- Device Name
- Clostridium Difficile TcdA Gene And TcdB Gene Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay) EUDAMED
- Model / Reference
- B28201T2048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895475686 EUDAMED
- Basic UDI-DI
- B-06970895475686 EUDAMED
- EMDN Code
- W0105011804 C.DIFFICILE BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
Clostridium Difficile TcdA Gene And TcdB Gene Nucleic Acid Test Kit (Fluorescen… by Jiangsu Mole Bioscience 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-06970895475686 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 7dbcb3fb-80d8-4171-beec-d451e5ece7a9 61 fields · synced Jul 10, 2026