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Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref 301100083000
Identity
- Device Name
- Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection Kit EUDAMED
- Model / Reference
- 301100083000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895475914 EUDAMED
- Basic UDI-DI
- B-06970895475914 EUDAMED
- EMDN Code
- W0105010403 H. PYLORI DETECTION 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
Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection 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-06970895475914 | 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 1f51e1b1-8ee5-49c4-8276-960570a55c17 61 fields · synced Jun 18, 2026