BioCLIA Autoimmune Calibrator Set, CENP-B

EUDAMED

Class IVD General (EU MDR)

Ref MY00211Model CENP-B, 2 x 1mL

by HOB Biotech Group Corp., Ltd.

Identity

Trade Name: BioCLIA Autoimmune Calibrator Set, CENP-B EUDAMED
Device Name: BioCLIA Autoimmune Calibrator Set, CENP-B EUDAMED
Model / Reference: CENP-B, 2 x 1mL EUDAMED
MY00211 EUDAMED

Identifiers

Primary DI / UDI-DI: 06924030403263 EUDAMED
Basic UDI-DI: B-06924030403263 EUDAMED
EMDN Code: W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER 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 Calibrator Set, CENP-B 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-06924030403263	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 5f501e8a-d384-4d79-af96-0dfd76d72fb5 61 fields · synced Oct 6, 2026