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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-IM4494127M8

Pepsinogen I Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494127M8
Basic UDI-DI: B-IM4494127M8
Reference: IM4494127
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494090MA

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-IM4494090MA
Basic UDI-DI: B-IM4494090MA
Reference: IM4494090
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 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494089MR

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-IM4494089MR
Basic UDI-DI: B-IM4494089MR
Reference: IM4494089
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 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494088MP

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-IM4494088MP
Basic UDI-DI: B-IM4494088MP
Reference: IM4494088
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 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494076MG

Anemia Markers Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494076MG
Basic UDI-DI: B-IM4494076MG
Reference: IM4494076
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494075ME

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-IM4494075ME
Basic UDI-DI: B-IM4494075ME
Reference: IM4494075
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494074MC

S100 Protein Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494074MC
Basic UDI-DI: B-IM4494074MC
Reference: IM4494074
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494073MA

Pregnancy Associated Plasma Protein-A Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494073MA
Basic UDI-DI: B-IM4494073MA
Reference: IM4494073
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494072M8

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-IM4494072M8
Basic UDI-DI: B-IM4494072M8
Reference: IM4494072
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 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4493471MK

Hypertension Marker Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4493471MK
Basic UDI-DI: B-IM4493471MK
Reference: IM4493471
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4493208M2

Anti-Müllerian Hormone (AMH) Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4493208M2
Basic UDI-DI: B-IM4493208M2
Reference: IM4493208
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494054J

Thyroid Function Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494054J
Basic UDI-DI: B-IM4494054J
Reference: IM4494051
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4493202LN

Hormones Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4493202LN
Basic UDI-DI: B-IM4493202LN
Reference: IM4493202
EMDN: W0102152002
EMDN description: HORMONE 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-IM4493159ME

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-IM4493159ME
Basic UDI-DI: B-IM4493159ME
Reference: IM4493159
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-IM4493158MC

BNP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4493158MC
Basic UDI-DI: B-IM4493158MC
Reference: IM4493158
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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-IM4493157MA

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-IM4493157MA
Basic UDI-DI: B-IM4493157MA
Reference: IM4493157
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-IM4493156M8

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-IM4493156M8
Basic UDI-DI: B-IM4493156M8
Reference: IM4493156
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-IM4493129M5

PIVKA-II Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4493129M5
Basic UDI-DI: B-IM4493129M5
Reference: IM4493129
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - 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-IM4493127LZ

Pepsinogen I Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4493127LZ
Basic UDI-DI: B-IM4493127LZ
Reference: IM4493127
EMDN: W0102069006
EMDN description: PEPSINOGEN
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-IM4493076M9

Anemia Markers Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4493076M9
Basic UDI-DI: B-IM4493076M9
Reference: IM4493076
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