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H. pylori Antigen Fast Test Kit (Immunofluorescence Assay)
EUDAMEDClass B (EU MDR)
Ref IF1047
Identity
- Device Name
- H. pylori Antigen Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Model / Reference
- IF1047 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414727159 EUDAMED
- Basic UDI-DI
- 695441470237HD EUDAMED
- EMDN Code
- W0105010401 H. PYLORI ANTIGEN DETECTION EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Austria 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
New Device
No
EUDAMED
H. pylori Antigen Fast Test Kit (Immunofluorescence Assay) by Getein Biotech, Inc. — 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 | 695441470237HD | Class B | Active |
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Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 4e9c78e9-bbaa-4076-bcf0-0212c233fa28 61 fields · synced Jun 20, 2026