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Helicobacter Pylori Antigen Rapid Test Cassette (Lateral Flow Method)
EUDAMEDClass IVD General (EU MDR)
Ref IC004
Identity
- Device Name
- Helicobacter Pylori Antigen Rapid Test Cassette (Lateral Flow Method) EUDAMED
- Model / Reference
- IC004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323019619 EUDAMED
- Basic UDI-DI
- B-06974323019619 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
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
Helicobacter Pylori Antigen Rapid Test Cassette (Lateral Flow Method) by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD — listed…
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-06974323019619 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 51e1ddff-20dd-4ebc-a5d1-4b3e6fc7dc45 61 fields · synced Jul 24, 2026