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Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucle…
EUDAMEDClass IVD General (EU MDR)
Ref B052T010B0C2
Identity
- Device Name
- Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucleic Acid Amplification Test Kit (Fluorescent Probe-Based Real-Time PCR Assay) EUDAMED
- Model / Reference
- B052T010B0C2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895477048 EUDAMED
- Basic UDI-DI
- B-06970895477048 EUDAMED
- EMDN Code
- W0105010403 H. PYLORI DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucle… 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-06970895477048 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 0c6831b6-9dc5-450b-b204-95135aaccbbe 61 fields · synced Jul 11, 2026