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H.Pylori Antigen Test kit
EUDAMEDClass IVD General (EU MDR)
Ref HPAg4FE-10Model Cassette Strip Tube
Identity
- Trade Name
- H.Pylori Antigen Test kit EUDAMED
- Device Name
- H.Pylori Antigen Test kit EUDAMED
- Model / Reference
- Cassette Strip Tube EUDAMEDHPAg4FE-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062773986 EUDAMED
- Basic UDI-DI
- B-06952062773986 EUDAMED
- EMDN Code
- W0105010401 H. PYLORI ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
H.Pylori Antigen Test kit by Anhui Deepblue Medical Technology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06952062773986 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Anhui Deepblue Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018785
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 0285b401-7fdc-4eea-bfa0-388aab0abb73 61 fields · synced Oct 7, 2026