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Immunoglobulin G

EUDAMED

Class IVD General (EU MDR)

Ref IGTUR-H00/ALI

by Diagam S.A.

Identity

Trade Name
Immunoglobulin G EUDAMED
Device Name
Immunoglobulin G EUDAMED
Model / Reference
IGTUR-H00/ALI EUDAMED

Identifiers

Primary DI / UDI-DI
05415168006392 EUDAMED
Basic UDI-DI
B-05415168006392 EUDAMED
EMDN Code
W0102010105 IMMUNOGLOBULIN G EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

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

Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

Immunoglobulin G by Diagam S.A. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Diagam S.A.
EUDAMED SRN
BE-MF-000022993

Sources (1)

  • EUDAMED 62810c91-944d-49b8-b6ef-d45cac4eb45c 61 fields · synced Jun 19, 2026