Helicheck
by Innovative Biotechnology Organization Trade Limited Company Türkiye EUDAMED
Ref HP010
EMDN W0105010499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number86816772HPJ9 | Date21 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Rapid Urease Test for Detection of Helicobacter Pylori by Looking at Urease Activity in Biopsy Samples
- Model / Reference
- HP010
- Primary DI / UDI-DI
- 08681677201512
- Basic UDI-DI
- 86816772HPJ9
- EMDN Code
- W0105010499 H. pylori reagents - other
- Device Class
- Class A
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000037634
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Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED b39ed0ea-0c90-4cae-a8e2-fd272b63fd52