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Helicobacter ViraChip IgG Deca Kit
EUDAMEDClass B (EU MDR)
Ref V-HPCGDKModel Helicobacter Kit
Identity
- Trade Name
- Helicobacter ViraChip IgG Deca Kit EUDAMED
- Device Name
- Helicobacter ViraChip IgA Test Kit EUDAMED
- Model / Reference
- Helicobacter Kit EUDAMEDV-HPCGDK EUDAMED
Identifiers
- Primary DI / UDI-DI
- EVIRHPCGDK1 EUDAMED
- Basic UDI-DI
- ++EVIRHelicobacterKitPE EUDAMED
- Direct Marketing DI
- EVIRHPCGDK1 EUDAMED
- EMDN Code
- W0105010402 H. PYLORI ANTIBODY ASSAYS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
New Device
No
EUDAMED
Helicobacter ViraChip IgG Deca Kit by Viramed Biotech AG — 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 | ++EVIRHelicobacterKitPE | Class B | Active |
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Manufacturer
- Manufacturer
- Viramed Biotech AG
- EUDAMED SRN
- DE-MF-000020368
Sources (1)
- EUDAMED 35a7af64-9294-4511-b004-e37499fcd78a 61 fields · synced Sep 17, 2026