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H. pylori Ag Determination Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass B (EU MDR)
Ref F11806Model 25 tests/box
Identity
- Trade Name
- H. pylori Ag Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- H. pylori Ag Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDF11806 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580309 EUDAMED
- Basic UDI-DI
- 697518250F118062U EUDAMED
- Direct Marketing DI
- 06942293580309 EUDAMED
- EMDN Code
- W0105010401 H. PYLORI ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
New Device
Yes
EUDAMED
H. pylori Ag Determination Kit (Fluorescence Immunochromatographic Assay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250F118062U | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED f5cf44f1-cec3-4ab3-8973-3e5a7affd1d0 61 fields · synced Jun 18, 2026