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

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D-IM4401056HJ

Anti-TG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401056HJ
Basic UDI-DI: B-IM4401056HJ
Reference: IM4401056
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4401055HG

TSH (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401055HG
Basic UDI-DI: B-IM4401055HG
Reference: IM4401055
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4401054HE

FT4 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401054HE
Basic UDI-DI: B-IM4401054HE
Reference: IM4401054
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4401053HC

total T4 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401053HC
Basic UDI-DI: B-IM4401053HC
Reference: IM4401053
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4401052HA

FT3 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401052HA
Basic UDI-DI: B-IM4401052HA
Reference: IM4401052
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4401051H8

total T3 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401051H8
Basic UDI-DI: B-IM4401051H8
Reference: IM4401051
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4401024H5

Aldosterone Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401024H5
Basic UDI-DI: B-IM4401024H5
Reference: IM4401024
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

D-IM4401023H3

Aldosterone Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401023H3
Basic UDI-DI: B-IM4401023H3
Reference: IM4401023
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

D-IM4401020GV

Aldosterone Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401020GV
Basic UDI-DI: B-IM4401020GV
Reference: IM4401020
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

D-IM4401019HC

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

D-IM4401010GS

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

D-IM4401008H7

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

D-IM4400790JE

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

D-IM4400789JV

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

D-IM4400788JT

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

D-IM4400690J9

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

D-IM4400689JQ

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

D-IM4400389J9

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

D-IM4400388J7

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

D-IM4400688JN

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