Identity
- Device Name
- Helicobacter pylori IgA ELISA EUDAMED
- Model / Reference
- ILE-HEL02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ILE-HEL0269 EUDAMED
- Basic UDI-DI
- B-ILE-HEL0269 EUDAMED
- EMDN Code
- W0105010402 H. PYLORI ANTIBODY ASSAYS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Helicobacter pylori IgA ELISA by Gold Standard Diagnostics Kassel GmbH — 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-ILE-HEL0269 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
- EUDAMED SRN
- DE-MF-000021646
Sources (1)
- EUDAMED 71cc930b-4bb1-42cf-a61e-9f88601c5498 61 fields · synced Oct 6, 2026