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H. pylori Ag Rapid Test Kit
EUDAMEDClass B (EU MDR)
Ref G11808Model 25 tests/box
Identity
- Trade Name
- H. pylori Ag Rapid Test Kit EUDAMED
- Device Name
- H. pylori Ag Rapid Test Kit EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDG11808 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580026 EUDAMED
- Basic UDI-DI
- 697518250G118083D EUDAMED
- Direct Marketing DI
- 06942293580026 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 Rapid Test Kit by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697518250G118083D | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 3e28be6b-dbd8-4ce9-bd55-e7f1bb248a43 61 fields · synced Jun 18, 2026