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Biocard Helicobacter pylori IgG
EUDAMEDClass IVD General (EU MDR)
Ref 3-018-110
Identity
- Trade Name
- Biocard Helicobacter pylori IgG EUDAMED
- Device Name
- Biocard Helicobacter pylori IgG EUDAMED
- Model / Reference
- 3-018-110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06416842818019 EUDAMED
- Basic UDI-DI
- B-06416842818019 EUDAMED
- EMDN Code
- W0105010402 H. PYLORI ANTIBODY ASSAYS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Biocard Helicobacter pylori IgG by Labsystems Diagnostics Oy — 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-06416842818019 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Labsystems Diagnostics Oy
- EUDAMED SRN
- FI-MF-000018281
Sources (1)
- EUDAMED 74727c49-05f3-4d84-baee-2f371a7b0e1f 61 fields · synced Jun 18, 2026