BioCLIA Autoimmune Reagent Kit, human tTG IgG

EUDAMED

Class IVD General (EU MDR)

Ref MY00190Model human tTG IgG, 100 Tests/Kit

by HOB Biotech Group Corp., Ltd.

Identity

Trade Name: BioCLIA Autoimmune Reagent Kit, human tTG IgG EUDAMED
Device Name: BioCLIA Autoimmune Reagent Kit, human tTG IgG EUDAMED
Model / Reference: human tTG IgG, 100 Tests/Kit EUDAMED
MY00190 EUDAMED

Identifiers

Primary DI / UDI-DI: 06924030403058 EUDAMED
Basic UDI-DI: B-06924030403058 EUDAMED
EMDN Code: W0102100601 TISSUE TRANSGLUTAMINASE ANTIBODIES EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

BioCLIA Autoimmune Reagent Kit, human tTG IgG by HOB Biotech Group Corp., Ltd. — 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-06924030403058	Class IVD General	Active

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Manufacturer

Manufacturer: HOB Biotech Group Corp., Ltd.
EUDAMED SRN: CN-MF-000023974
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (1)

EUDAMED 978aaf3a-6a14-4615-9fc5-26f5e4fd230d 61 fields · synced Jun 18, 2026