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Immune Globulin E (IgE) Test Kit (Immunoturbidimetric)

EUDAMED

Class IVD General (EU MDR)

Ref Calibrator：1mL×5（91041）

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name: Immune Globulin E (IgE) Test Kit (Immunoturbidimetric) EUDAMED
Device Name: Immune Globulin E (IgE) Test Kit (Immunoturbidimetric) EUDAMED
Model / Reference: Calibrator：1mL×5（91041） EUDAMED

Identifiers

Primary DI / UDI-DI: 06971674868071 EUDAMED
Basic UDI-DI: B-06971674868071 EUDAMED
EMDN Code: W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED

Classification

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

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

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: Nucleic acid extraction/isolation kit IVD

Immune Globulin E (IgE) Test Kit (Immunoturbidimetric) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Biobase Biodustry(Shandong) Co., Ltd.
EUDAMED SRN: CN-MF-000025015
Authorised Representative: Luxus Lebenswelt GmbH DE-AR-000005110

Sources (1)

EUDAMED da174677-2a6b-4567-be9d-5be6318698b9 61 fields · synced Jun 19, 2026