Public EUDAMED Search

EUDAMED Device Search

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

TR EN

Last updated

18.09.2026 02:35

Sync status

Successful

Device

3108040

Actor

47631

Certificate

3283

Filters

Show filters

Active filter:EMDN:W0102100110

40 device results listed.

Page 1 / 2

CSV XML

Scl-70

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: AIDA GmbH
Manufacturer SRN: DE-MF-000040784
UDI-DI: 04260158680110
Basic UDI-DI: B-04260158680110
Reference: 10111
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:38

Manufacturer products View details

Anti-Scl-70 Antibody CLIA Assay Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224667
Basic UDI-DI: B-06975424224667
Reference: CL30401E
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Scl-70 Antibody CLIA Assay Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224650
Basic UDI-DI: B-06975424224650
Reference: CL20401E
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Scl-70

Scl-70, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415525
Basic UDI-DI: B-06924030415525
Reference: MY00103C
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Scl-70

Scl-70, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404222
Basic UDI-DI: B-06924030404222
Reference: MY00307
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, Scl-70

Scl-70, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403201
Basic UDI-DI: B-06924030403201
Reference: MY00205
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Scl-70

Scl-70, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402693
Basic UDI-DI: B-06924030402693
Reference: MY00154
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

IDS Jo-1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693869
Basic UDI-DI: B-05060169693869
Reference: IS-AI1109
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

IDS Scl-70

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693852
Basic UDI-DI: B-05060169693852
Reference: IS-AI1108
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

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: 06942359544986
Basic UDI-DI: 697015090000308HF
Reference: CMQ1805
EMDN: W0102100110
EMDN description: SCL-70
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

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: 06942359544962
Basic UDI-DI: 697015090000308HF
Reference: CMQ1803
EMDN: W0102100110
EMDN description: SCL-70
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products View details

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

Manufacturer products View details

AESKULISA® Scl-70

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500531
Basic UDI-DI: B-04250289500531
Reference: 3111
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: -
Last updated: 20.07.2026 18:37

Manufacturer products View details

Anti-Scl-70 Antibody CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424226579
Basic UDI-DI: B-06975424226579
Reference: CL20402EN
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4422259JX

Anti-Scl-70 Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4422259JX
Basic UDI-DI: B-IM4422259JX
Reference: IM4422259
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

Scl-70

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147193768
Basic UDI-DI: B-86060147193768
Reference: N712A24SCL
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:13

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® Scl-70 Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950724476
Basic UDI-DI: B-08426950724476
Reference: 701328
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Scl-70 Assay Kit (Fluorescence Immunoassay)

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424225619
Basic UDI-DI: B-06975424225619
Reference: DL234401C
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Scl-70 Antibody CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224049
Basic UDI-DI: B-06975424224049
Reference: CL30402EN
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details