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Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）

EUDAMED

Class IVD General (EU MDR)

Ref MY-0020-01Model Model 1:Food group 1 (egg white f1, milk f2, cod f3, crab f23, shrimp f24,beef f27) 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 1:Food group 1 (egg white f1, milk f2, cod f3, crab f23, shrimp f24,beef f27) 25 tests/kit EUDAMED
MY-0020-01 EUDAMED

Identifiers

Primary DI / UDI-DI
06976117454835 EUDAMED
Basic UDI-DI
B-06976117454835 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

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

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

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

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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 479902c6-9307-40c4-b779-8226c1fdef54 61 fields · synced Jun 18, 2026