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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-IM4495471MZ

Hypertension Marker Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4495471MZ
Basic UDI-DI: B-IM4495471MZ
Reference: IM4495471
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4496051ME

Thyroid Function Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4496051ME
Basic UDI-DI: B-IM4496051ME
Reference: IM4496051
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4495268N2

Rheumatoid Control Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4495268N2
Basic UDI-DI: B-IM4495268N2
Reference: IM4495268
EMDN: W0102152010
EMDN description: CONTROLS FOR RHEUMATOLOGY
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-IM4495208MG

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-IM4495208MG
Basic UDI-DI: B-IM4495208MG
Reference: IM4495208
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-IM4495202M4

Hormones Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4495202M4
Basic UDI-DI: B-IM4495202M4
Reference: IM4495202
EMDN: W0102152002
EMDN description: HORMONE 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-IM4495158MS

BNP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4495158MS
Basic UDI-DI: B-IM4495158MS
Reference: IM4495158
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 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4495128MH

Pepsinogen II Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4495128MH
Basic UDI-DI: B-IM4495128MH
Reference: IM4495128
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-IM4495090MH

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-IM4495090MH
Basic UDI-DI: B-IM4495090MH
Reference: IM4495090
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-IM4495089MY

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-IM4495089MY
Basic UDI-DI: B-IM4495089MY
Reference: IM4495089
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-IM4495088MW

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-IM4495088MW
Basic UDI-DI: B-IM4495088MW
Reference: IM4495088
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-IM4495076MP

Anemia Markers Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4495076MP
Basic UDI-DI: B-IM4495076MP
Reference: IM4495076
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-IM4495075MM

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-IM4495075MM
Basic UDI-DI: B-IM4495075MM
Reference: IM4495075
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-IM4495072MF

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-IM4495072MF
Basic UDI-DI: B-IM4495072MF
Reference: IM4495072
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-IM4495051M7

Thyroid Function Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4495051M7
Basic UDI-DI: B-IM4495051M7
Reference: IM4495051
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-IM4494471MS

Hypertension Marker Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494471MS
Basic UDI-DI: B-IM4494471MS
Reference: IM4494471
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-IM4494268MT

Rheumatoid Control Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494268MT
Basic UDI-DI: B-IM4494268MT
Reference: IM4494268
EMDN: W0102152010
EMDN description: CONTROLS FOR RHEUMATOLOGY
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-IM4494202LV

Hormones Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494202LV
Basic UDI-DI: B-IM4494202LV
Reference: IM4494202
EMDN: W0102152002
EMDN description: HORMONE 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-IM4494158MK

BNP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494158MK
Basic UDI-DI: B-IM4494158MK
Reference: IM4494158
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 01:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4494129MC

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-IM4494129MC
Basic UDI-DI: B-IM4494129MC
Reference: IM4494129
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - 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-IM4494128MA

Pepsinogen II Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4494128MA
Basic UDI-DI: B-IM4494128MA
Reference: IM4494128
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