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H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref B05201T2048Ref B058T050B0C2
Identity
- Device Name
- H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit EUDAMED
- Model / Reference
- B05201T2048 EUDAMEDB058T050B0C2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895475518 EUDAMED06970895475969 EUDAMED06970895476034 EUDAMED
- Basic UDI-DI
- B-06970895475518 EUDAMEDB-06970895475969 EUDAMEDB-06970895476034 EUDAMED
- EMDN Code
- W0105010403 H. PYLORI DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMEDCzechia 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
H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit by Jiangsu Mole Bioscience Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
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-06970895475518 | 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 (3)
- EUDAMED cc0bac7e-a14c-4588-87bf-1d1d09ae7df7 61 fields · synced Oct 6, 2026
- EUDAMED 6def93cf-453c-493c-9006-371279e177c9 61 fields · synced May 18, 2026
- EUDAMED c693012e-78c4-4441-98fe-41a39dc6bb8f 61 fields · synced Jul 9, 2026