Identity
- Trade Name
- Helori Urease EUDAMED
- Device Name
- Helori Urease EUDAMED
- Model / Reference
- 1693 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08028169200644 EUDAMED
- Basic UDI-DI
- 802816920BW01050503013Y EUDAMED
- EMDN Code
- W0105090102 H. PYLORI - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy 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
New Device
No
EUDAMED
Helori Urease by Eurospital Spa — 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 | 802816920BW01050503013Y | Class B | Active |
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Manufacturer
- Manufacturer
- Eurospital Spa
- EUDAMED SRN
- IT-MF-000028468
Sources (1)
- EUDAMED 301413ad-48fb-4ba6-a03a-291b34d8490f 61 fields · synced Jul 19, 2026