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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-IM4492159M7

D-Dimer Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492159M7
Basic UDI-DI: B-IM4492159M7
Reference: IM4492159
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4492157M3

High Sensitive Troponin T Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492157M3
Basic UDI-DI: B-IM4492157M3
Reference: IM4492157
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4492156LZ

High Sensitive Troponin I Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492156LZ
Basic UDI-DI: B-IM4492156LZ
Reference: IM4492156
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4492155LX

GDF-15 Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492155LX
Basic UDI-DI: B-IM4492155LX
Reference: IM4492155
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4492076M2

Anemia Markers Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492076M2
Basic UDI-DI: B-IM4492076M2
Reference: IM4492076
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4492075LY

Cardiac Markers Control Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492075LY
Basic UDI-DI: B-IM4492075LY
Reference: IM4492075
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4492051LJ

Thyroid Function Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492051LJ
Basic UDI-DI: B-IM4492051LJ
Reference: IM4492051
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4492043LK

HEV 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-IM4492043LK
Basic UDI-DI: B-IM4492043LK
Reference: IM4492043
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4492022LB

Serum amyloid A Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492022LB
Basic UDI-DI: B-IM4492022LB
Reference: IM4492022
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4492017LJ

HEV 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-IM4492017LJ
Basic UDI-DI: B-IM4492017LJ
Reference: IM4492017
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491471M5

Hypertension Marker Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491471M5
Basic UDI-DI: B-IM4491471M5
Reference: IM4491471
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491304LH

Inflammation Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491304LH
Basic UDI-DI: B-IM4491304LH
Reference: IM4491304
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491268M6

Rheumatoid Control Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491268M6
Basic UDI-DI: B-IM4491268M6
Reference: IM4491268
EMDN: W0102152010
EMDN description: CONTROLS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491202L8

Hormones Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491202L8
Basic UDI-DI: B-IM4491202L8
Reference: IM4491202
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491159LY

D-Dimer Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491159LY
Basic UDI-DI: B-IM4491159LY
Reference: IM4491159
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491157LU

High Sensitive Troponin T Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491157LU
Basic UDI-DI: B-IM4491157LU
Reference: IM4491157
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491156LS

High Sensitive Troponin I Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491156LS
Basic UDI-DI: B-IM4491156LS
Reference: IM4491156
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491155LQ

GDF-15 Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491155LQ
Basic UDI-DI: B-IM4491155LQ
Reference: IM4491155
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491076LT

Anemia Markers Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491076LT
Basic UDI-DI: B-IM4491076LT
Reference: IM4491076
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491075LR

Cardiac Markers Control Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491075LR
Basic UDI-DI: B-IM4491075LR
Reference: IM4491075
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details