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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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01.08.2026 18:27

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31 device results listed.

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IM4410259 IM4411259 IM4415259 IM4422259

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617406655
Basic UDI-DI: 69506174IM441259E6
Reference: IM4411259
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:44

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410259 IM4411259 IM4415259 IM4422259

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617406648
Basic UDI-DI: 69506174IM441259E6
Reference: IM4410259
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:44

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Scl-70 IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359512718
Basic UDI-DI: 697015090000308HF
Reference: CMQ1810
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Greece
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Scl-70 IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359512695
Basic UDI-DI: 697015090000308HF
Reference: CMQ1808
EMDN: W0102100110
EMDN description: SCL-70
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 26.06.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDot Scleroderma12 IgG

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IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680889
Basic UDI-DI: 542502368BDSCLERODERMAK9
Reference: SCL12D-24
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

BlueDiverDot Scleroderma12 IgG

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IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681800
Basic UDI-DI: 542502368BDDSCLERODERMAKH
Reference: SCL12DIV-24
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:24

Manufacturer products View details

Scleroderma Profile 10 Ag Dot

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IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687246
Basic UDI-DI: 542502368BDSCLERODERMAK9
Reference: AD SCLERO10D
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

Scleroderma Profile 12 Ag Dot

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IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687253
Basic UDI-DI: 542502368BDSCLERODERMAK9
Reference: AD SCLERO12D
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

Scleroderma Profile 10 Ag Dot for BDI

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IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687543
Basic UDI-DI: 542502368BDDSCLERODERMAKH
Reference: AD SCLERO10DBD
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

Scleroderma Profile 12 Ag Dot for BDI

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IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687550
Basic UDI-DI: 542502368BDDSCLERODERMAKH
Reference: AD SCLERO12DBD
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: -
Last updated: 25.06.2026 17:23

Manufacturer products View details

Anti-Scl-70 Antibody CLIA Assay Kit

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IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424222595
Basic UDI-DI: B-06975424222595
Reference: CL30402E
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:32

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