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

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ARCHITECT

ARCHITECT Total T4

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740129453
Basic UDI-DI: 038074ARK0766NL
Reference: 07K6602
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT BHCG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014933
Basic UDI-DI: 038074AIK0778K6
Reference: 07K7801
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT Prolactin

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014834
Basic UDI-DI: 038074ARK0776NP
Reference: 07K7601
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT FSH

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014780
Basic UDI-DI: 038074ARK0775NM
Reference: 07K7501
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT Total PSA

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740014599
Basic UDI-DI: 038074ARK0770NB
Reference: 07K7001
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

Architect CEA

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740014544
Basic UDI-DI: 038074ARK0768NQ
Reference: 07K6802
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT Free T4

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014360
Basic UDI-DI: 038074ARK0765NJ
Reference: 07K6510
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

ARCHITECT Total T3

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014346
Basic UDI-DI: 038074ARK0764NG
Reference: 07K6450
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:39

Manufacturer products View details

ARCHITECT

Architect TSH

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014209
Basic UDI-DI: 038074ARK0762NC
Reference: 07K6201
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 07:38

Manufacturer products View details

ARCHITECT

ARCHITECT Ferritin

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland Diagnostics Division
Manufacturer SRN: IE-MF-000010070
UDI-DI: 00380740014070
Basic UDI-DI: 038074ARK0759NP
Reference: 07K5901
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 07:38

Manufacturer products View details

Jasem Vitamin K LC-MS/MS Analysis Kit

IVD Class BNot specifiedOn the marketSingle use

Manufacturer: Altium International Laboratuvar Cihazları A.Ş.
Manufacturer SRN: TR-MF-000055813
UDI-DI: 08681057482630
Basic UDI-DI: 86810574802700XV
Reference: JSM-CL-2700
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 23.09.2026 07:33

Manufacturer products View details

AccuProbe Influenza A Virus PCR Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hecin Scientific, Inc.
Manufacturer SRN: CN-MF-000019106
UDI-DI: 06973349141229
Basic UDI-DI: 697334914HSB45K2
Reference: HSB45-10
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 23.09.2026 07:14

Manufacturer products Authorised representative products Authorised representative actors View details

QuikRead go easy CRP

IVD Class CNot specifiedOn the market

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001430
Basic UDI-DI: 6438115QRgoeasyCRPJP
Reference: 153287
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 23.09.2026 07:07

Manufacturer products View details

Serumopløsning til (KCA)

Culture Media - General agar plates and tubes

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106987872
Basic UDI-DI: 5713106CM_GeneralZL
Reference: 98787
EMDN: W0104010206
EMDN description: MEDIA IN TUBES (SOLID & LIQUID)
First on market country: Denmark
Authorised representative: -
Last updated: 23.09.2026 07:02

Manufacturer products View details

Mobile Phase A

MassChrom® Biogenic Amines/Metabolites in urine Starter Set Chromatographic Platform

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317536617
Basic UDI-DI: 4250317800005C
Reference: 80001
EMDN: W01010499
EMDN description: MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 06:51

Manufacturer products View details

Mobile Phase A

MassTox® Immunosuppressants in whole blood

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Chromsystems Instruments + Chemicals GmbH
Manufacturer SRN: DE-MF-000010089
UDI-DI: 04250317530912
Basic UDI-DI: 4250317930006C
Reference: 93911
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 06:51

Manufacturer products View details

Acido periodico 1% 1 flacone da 1 litro

Staining kit, solvents and reagents for pathological anatomy

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Bio-Optica Milano S.p.A.
Manufacturer SRN: IT-MF-000027525
UDI-DI: 08033976232184
Basic UDI-DI: 080339762W01030799Y5
Reference: 05-05030/L
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.09.2026 06:44

Manufacturer products View details

Hematology Calibrator

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377306965
Basic UDI-DI: 697049309W01033013002CD
Reference: XQ-0103-02
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Calibrator

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377306972
Basic UDI-DI: 697049309W01033013002CD
Reference: XQ-0103-03
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

Model:DM-6DR,Specification：3mL（L）×1+3mL（N）×1+ 3mL（H）×1、2mL（L）×1+2mL（N）×1+ 2mL（H）×1

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377306989
Basic UDI-DI: 697049309W01033013001CB
Reference: XQ-0093-01
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 06:42

Manufacturer products Authorised representative products Authorised representative actors View details