Identity
- Trade Name
- Amplidiag H. pylori+ClariR Kit EUDAMED
- Device Name
- Amplidiag H. pylori+ClariR Kit EUDAMED
- Model / Reference
- AD-HP-80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430041761327 EUDAMED
- Basic UDI-DI
- B-06430041761327 EUDAMED
- EMDN Code
- W0105010403 H. PYLORI DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Amplidiag H. pylori+ClariR Kit by Mobidiag Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06430041761327 | Class IVD General | No Longer Active |
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Manufacturer
- Manufacturer
- Mobidiag Ltd.
- EUDAMED SRN
- FI-MF-000001215
Sources (1)
- EUDAMED 642c42ae-ad26-44eb-a818-2ce0f2c7eebf 61 fields · synced Jul 17, 2026