Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）

EUDAMED

Class IVD General (EU MDR)

Ref MY-0021-01Model Model 4:Inhalation group 2 (common birch t3, maple sycamore t11, willowt12, alternaria m6,aspergillus fumigatus m3,mugwort w6) 25 tests/kit

by Shenzhen Dymind Biotechnology Co., Ltd.

Identity

Trade Name: Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry） EUDAMED
Device Name: Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry） EUDAMED
Model / Reference: Model 4:Inhalation group 2 (common birch t3, maple sycamore t11, willowt12, alternaria m6,aspergillus fumigatus m3,mugwort w6) 25 tests/kit EUDAMED
MY-0021-01 EUDAMED

Identifiers

Primary DI / UDI-DI: 06976117454897 EUDAMED
Basic UDI-DI: B-06976117454897 EUDAMED
EMDN Code: W01020204 IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry） by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

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-06976117454897	Class IVD General	Active

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Manufacturer

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
EUDAMED SRN: CN-MF-000024842
Authorised Representative: Eunitor GmbH DE-AR-000005081

Sources (1)

EUDAMED 4816da37-a04b-4320-93bb-9f042f7b2c6d 61 fields · synced Jun 11, 2026