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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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BlueDiverDot Granular12 IgG

BlueDiver Dot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681824
Basic UDI-DI: 542502368BDDGRANULARDB
Reference: GR12DIV-24
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Synthetase10 IgG

BlueDiverDot Myositis

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681732
Basic UDI-DI: 542502368BDDMYOSITISTF
Reference: SYN10DIV-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Scleroderma10 IgG

BlueDiverDot Scleroderma

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681725
Basic UDI-DI: 542502368BDDSCLERODERMAKH
Reference: SCL10DIV-24
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot GAD IgG

BlueDiverDot GAD

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681664
Basic UDI-DI: 542502368BDDGADYB
Reference: GADIV-24 IgG
EMDN: W0102100299
EMDN description: NEURO-AUTO-IMMUNE DISEASE - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Celiac IgA

BlueDiverDot Celiac

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681626
Basic UDI-DI: 542502368BDDCELIACR5
Reference: ENDADIV-24
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Polymyositis/Scleroderma8 IgG

BlueDiverDot Polymyositis/Scleroderma

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681589
Basic UDI-DI: 542502368BDDPMSCLLT
Reference: PMS8DIV-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Liver5 IgG

BlueDiverDot Liver

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681497
Basic UDI-DI: 542502368BDDLIVERKL
Reference: LISDIV-24
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Gastritis IgG

BlueDiverDot Gastritis

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681473
Basic UDI-DI: 542502368BDDGASTRITISC2
Reference: IFPCADIV-24
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Cytoplasm6 IgG

BlueDiver Dot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681428
Basic UDI-DI: 542502368BDDCYTOPLASMKG
Reference: CY6DIV-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Chromatin IgG

BlueDiver Dot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681398
Basic UDI-DI: 542502368BDDCHROMATIN6Y
Reference: CHRDIV-24
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot APS IgG

BlueDiverDot APS

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681367
Basic UDI-DI: 542502368BDDAPSZQ
Reference: APSGDIV-24
EMDN: W0102100599
EMDN description: ANTI-PHOSPHOLIP SYNDROME - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot ANCA+GBM IgG

BlueDiverDot ANCA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681350
Basic UDI-DI: 542502368BDDANCA4F
Reference: ANCAGDIV-24
EMDN: W0102100401
EMDN description: ANCA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot ANA8 IgG

BlueDiver Dot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681305
Basic UDI-DI: 542502368BDDANAYE
Reference: ANA8DIV-24
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot Granular12 IgG

BlueDot Granular

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680902
Basic UDI-DI: 542502368BDGRANULARQV
Reference: GR12D-24
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot Scleroderma10 IgG

BlueDot Scleroderma

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680766
Basic UDI-DI: 542502368BDSCLERODERMAK9
Reference: SCL10D-24
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot Myositis7 IgG

BlueDot Myositis

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680742
Basic UDI-DI: 542502368BDMYOSITIS74
Reference: MYO7D-24
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot GAD IgG

BlueDot GAD

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680704
Basic UDI-DI: 542502368BDGADZC
Reference: GAD-24
EMDN: W0102100299
EMDN description: NEURO-AUTO-IMMUNE DISEASE - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot Chromatin IgG

BlueDot Chromatin IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680568
Basic UDI-DI: 542502368BDCHROMATINFW
Reference: CHRD-24
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot Polymyositis/Scleroderma8 IgG

BlueDot Polymyositis/Scleroderma

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680551
Basic UDI-DI: 542502368BDPMSCLCN
Reference: PMS8D-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot Liver5 IgG

BlueDot Liver

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680483
Basic UDI-DI: 542502368BDLIVERBF
Reference: LISD-24
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details