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Allergen-Specific IgE Antibody Kit (Fluorescence flow cytometry）

EUDAMED

Class IVD General (EU MDR)

Ref MY-0026-02Model 50 tests/kit,Model 1(food group 1)Ref MY-0020-02Model Model 2:Food group 2 (wheat f4,sesamef10,peanutf13,soybean f14,mutton f88) 25 tests/kitRef MY-0023-01Model Model 7:Comprehensive mix group (food group 1 + food group 2 + inhalation group 1 + inhalation group 2) 25 tests/kitRef MY-0025-01Model Model 4:Inhalation group 2 (common birch t3, maple sycamore t11, willowt12, alternaria m6,aspergillus fumigatus m3,mugwort w6) 50 tests/kitRef MY-0026-01Model Model 6:Comprehensive inhalation group (inhalation group 1 + inhalation group 2 ) 50 tests/kitRef MY-0024-02Model Model 3:Inhalation group 1 (house dust mited1,dust mite d2, cockroachi6,cat dandere1,dogdandere5,common ragweedw1) 50 tests/kitRef MY-0016-01Model Model 3:Inhalation group 1 (house dust mited1,dust mite d2, cockroachi6,cat dandere1,dogdandere5,common ragweedw1) 25 tests/kit

by Shenzhen Dymind Biotechnology Co., Ltd.

Identity

Trade Name
Allergen-Specific IgE Antibody Kit (Fluorescence flow cytometry） EUDAMED
Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry） EUDAMED
Device Name
Allergen-Specific IgE Antibody Kit (Fluorescence flow cytometry） EUDAMED
Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry） EUDAMED
Model / Reference
50 tests/kit,Model 1(food group 1) EUDAMED
MY-0026-02 EUDAMED
Model 2:Food group 2 (wheat f4,sesamef10,peanutf13,soybean f14,mutton f88) 25 tests/kit EUDAMED
MY-0020-02 EUDAMED
Model 7:Comprehensive mix group (food group 1 + food group 2 + inhalation group 1 + inhalation group 2) 25 tests/kit EUDAMED
MY-0023-01 EUDAMED
Model 4:Inhalation group 2 (common birch t3, maple sycamore t11, willowt12, alternaria m6,aspergillus fumigatus m3,mugwort w6) 50 tests/kit EUDAMED
MY-0025-01 EUDAMED
Model 6:Comprehensive inhalation group (inhalation group 1 + inhalation group 2 ) 50 tests/kit EUDAMED
MY-0026-01 EUDAMED
Model 3:Inhalation group 1 (house dust mited1,dust mite d2, cockroachi6,cat dandere1,dogdandere5,common ragweedw1) 50 tests/kit EUDAMED
MY-0024-02 EUDAMED
Model 3:Inhalation group 1 (house dust mited1,dust mite d2, cockroachi6,cat dandere1,dogdandere5,common ragweedw1) 25 tests/kit EUDAMED
MY-0016-01 EUDAMED

Identifiers

Primary DI / UDI-DI
06976117454842 EUDAMED
06941377301373 EUDAMED
06976117454811 EUDAMED
06976117454903 EUDAMED
06941377301366 EUDAMED
06976117454880 EUDAMED
06976117454873 EUDAMED
Basic UDI-DI
B-06976117454842 EUDAMED
B-06941377301373 EUDAMED
B-06976117454811 EUDAMED
B-06976117454903 EUDAMED
B-06941377301366 EUDAMED
B-06976117454880 EUDAMED
B-06976117454873 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

No

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMEDEUDAMED

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 (7)

  • EUDAMED 7412d71c-6a91-47a1-81a0-c996a08b023b 61 fields · synced Oct 6, 2026
  • EUDAMED 51db9d46-3cc7-4c97-a533-9986b1ffca29 61 fields · synced Jun 18, 2026
  • EUDAMED 84265496-baf5-4aeb-ba3d-214a72f8db46 61 fields · synced Jul 9, 2026
  • EUDAMED 8b1841fa-81ac-49f2-8dee-c6e033a9ac90 61 fields · synced Jul 11, 2026
  • EUDAMED db67eb93-77a4-4c68-981f-799538e5f4b4 61 fields · synced Jul 13, 2026
  • EUDAMED 031de6f2-d71e-4474-afec-62652d6bc818 61 fields · synced Jul 17, 2026
  • EUDAMED d4c6ade5-c95b-4bc7-bc06-ced931b332ae 61 fields · synced Sep 18, 2026