Biocard™ H pylori IgG Home

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref 3-018-200

by Labsystems Diagnostics Oy

Identity

Trade Name: Biocard™ H pylori IgG Home EUDAMED
Device Name: 3-018-200 EUDAMED
Model / Reference: 3-018-200 EUDAMED

Identifiers

Primary DI / UDI-DI: 06416842918030 EUDAMED
Basic UDI-DI: B-06416842918030 EUDAMED
EMDN Code: W0105010402 H. PYLORI ANTIBODY ASSAYS EUDAMED

Classification

Device Class: Class IVD devices for self-testing EUDAMED
Market of Registration: Finland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

Yes

EUDAMED

Surgical Instrument

EUDAMED

Biocard™ H pylori IgG Home by Labsystems Diagnostics Oy — Class IVD devices for self-testing — 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-06416842918030	Class IVD devices for self-testing	Active

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Manufacturer

Manufacturer: Labsystems Diagnostics Oy
EUDAMED SRN: FI-MF-000018281

Sources (1)

EUDAMED 1abe5317-db0e-4baa-ba48-1dbf1efc3a7e 61 fields · synced Jun 19, 2026