Vitamin B12 Kit（CLIA)

EUDAMED

Class IVD General (EU MDR)

Ref CA1453AModel 50T

by Jiangxi Medicalsystem Biological Technology Co., Ltd.

Identity

Trade Name: Vitamin B12 Kit（CLIA) EUDAMED
Device Name: Vitamin B12 Kit(CLIA) EUDAMED
Model / Reference: 50T EUDAMED
CA1453A EUDAMED

Identifiers

Primary DI / UDI-DI: 06978945081269 EUDAMED
Basic UDI-DI: B-06978945081269 EUDAMED
EMDN Code: W0102070204 VITAMIN B12 EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Vitamin B12 Kit（CLIA) by Jiangxi Medicalsystem Biological Technology Co., 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-06978945081269	Class IVD General	Active

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Manufacturer

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
EUDAMED SRN: CN-MF-000050651
Authorised Representative: Medunion S.L. ES-AR-000019366

Sources (1)

EUDAMED d404ab2f-d8e9-47f2-9909-57ec25bef197 61 fields · synced Jul 9, 2026