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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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D-IM4414040J3

Mycoplasma Pneumoniae IgG 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-IM4414040J3
Basic UDI-DI: B-IM4414040J3
Reference: IM4414040
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4412472JN

Anti-β2 Glycoprotein 1 IgG Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4412472JN
Basic UDI-DI: B-IM4412472JN
Reference: IM4412472
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 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411472JF

Anti-β2 Glycoprotein 1 IgG Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411472JF
Basic UDI-DI: B-IM4411472JF
Reference: IM4411472
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 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411471JD

Anti-gp210 Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411471JD
Basic UDI-DI: B-IM4411471JD
Reference: IM4411471
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 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411470JB

Anti-LC-1 Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411470JB
Basic UDI-DI: B-IM4411470JB
Reference: IM4411470
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 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411469JS

Anti-sp100 Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411469JS
Basic UDI-DI: B-IM4411469JS
Reference: IM4411469
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 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411468JQ

Anti-LKM-1 Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411468JQ
Basic UDI-DI: B-IM4411468JQ
Reference: IM4411468
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 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411460J8

Anti-GBM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411460J8
Basic UDI-DI: B-IM4411460J8
Reference: IM4411460
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411459JP

Anti-MPO Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411459JP
Basic UDI-DI: B-IM4411459JP
Reference: IM4411459
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 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411458JM

Anti-SLA/LP Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411458JM
Basic UDI-DI: B-IM4411458JM
Reference: IM4411458
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 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411457JK

Anti-PR3 Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411457JK
Basic UDI-DI: B-IM4411457JK
Reference: IM4411457
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 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411271J3

RF-IgA Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411271J3
Basic UDI-DI: B-IM4411271J3
Reference: IM4411271
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411268JE

RF Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411268JE
Basic UDI-DI: B-IM4411268JE
Reference: IM4411268
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411267JC

AMA-M2 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411267JC
Basic UDI-DI: B-IM4411267JC
Reference: IM4411267
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 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411270HZ

RF-IgM Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411270HZ
Basic UDI-DI: B-IM4411270HZ
Reference: IM4411270
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411269JG

RF-IgG Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411269JG
Basic UDI-DI: B-IM4411269JG
Reference: IM4411269
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:33

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411266JA

Anti-PCNA 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-IM4411266JA
Basic UDI-DI: B-IM4411266JA
Reference: IM4411266
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 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411265J8

Anti-PM-Scl Anitibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411265J8
Basic UDI-DI: B-IM4411265J8
Reference: IM4411265
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411264J6

Anti-histone Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411264J6
Basic UDI-DI: B-IM4411264J6
Reference: IM4411264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4411257J9

Anti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4411257J9
Basic UDI-DI: B-IM4411257J9
Reference: IM4411257
EMDN: W0102100112
EMDN description: SS-A
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details