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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Aldosterone Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401019HC
Basic UDI-DI: B-IM4401019HC
Reference: IM4401019
EMDN: W0102060201
EMDN description: ALDOSTERONE
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401010GS
Basic UDI-DI: B-IM4401010GS
Reference: IM4401010
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401008H7
Basic UDI-DI: B-IM4401008H7
Reference: IM4401008
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400790JE
Basic UDI-DI: B-IM4400790JE
Reference: IM4400790
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 IgA Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400789JV
Basic UDI-DI: B-IM4400789JV
Reference: IM4400789
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 IgM Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400788JT
Basic UDI-DI: B-IM4400788JT
Reference: IM4400788
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400690J9
Basic UDI-DI: B-IM4400690J9
Reference: IM4400690
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 IgA Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400689JQ
Basic UDI-DI: B-IM4400689JQ
Reference: IM4400689
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 IgA Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400389J9
Basic UDI-DI: B-IM4400389J9
Reference: IM4400389
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Germany
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 IgM Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400388J7
Basic UDI-DI: B-IM4400388J7
Reference: IM4400388
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 IgM Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400688JN
Basic UDI-DI: B-IM4400688JN
Reference: IM4400688
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400390HS
Basic UDI-DI: B-IM4400390HS
Reference: IM4400390
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400290HM
Basic UDI-DI: B-IM4400290HM
Reference: IM4400290
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 IgA Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400289J4
Basic UDI-DI: B-IM4400289J4
Reference: IM4400289
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2 Glycoprotein 1 IgM Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4400288J2
Basic UDI-DI: B-IM4400288J2
Reference: IM4400288
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4291315KU
Basic UDI-DI: B-IM4291315KU
Reference: IM4291315
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (MYO) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4106203H3
Basic UDI-DI: B-IM4106203H3
Reference: IM4106203
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I (cTnI) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4106202GZ
Basic UDI-DI: B-IM4106202GZ
Reference: IM4106202
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Isoenzyme MB (CK-MB) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4106201GX
Basic UDI-DI: B-IM4106201GX
Reference: IM4106201
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (MYO) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4105203GU
Basic UDI-DI: B-IM4105203GU
Reference: IM4105203
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details