Veriler yükleniyor…

Public EUDAMED Search

EUDAMED Device Search

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

Last updated

22.09.2026 16:13

Sync status

Successful

Device

3537292

Actor

47759

Certificate

3388

Filters

Show filters

Active filter:EMDN:W01021001

813 device results listed.

Page 12 / 41

AESKULISA® SS-A-60

AESKULISA® SS-A-60

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500500
Basic UDI-DI: B-04250289500500
Reference: 3108
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:44

Manufacturer products View details

AESKULISA® SS-A

AESKULISA® SS-A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500494
Basic UDI-DI: B-04250289500494
Reference: 3107
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:44

Manufacturer products View details

AESKULISA® Sm

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500487
Basic UDI-DI: B-04250289500487
Reference: 3106
EMDN: W0102100111
EMDN description: SM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:44

Manufacturer products View details

AESKULISA® snRNP-C

AESKULISA® snRNP-C

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500470
Basic UDI-DI: B-04250289500470
Reference: 3105
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:44

Manufacturer products View details

AESKULISA® U1-70

AESKULISA® U1-70

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500463
Basic UDI-DI: B-04250289500463
Reference: 3104
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

AESKULISA® ENA-6Pro

AESKULISA® ENA-6Pro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500456
Basic UDI-DI: B-04250289500456
Reference: 3103
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

AESKULISA® ENA-6S

AESKULISA® ENA-6S

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500449
Basic UDI-DI: B-04250289500449
Reference: 3102
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

AESKULISA® ANA-8Pro

AESKULISA® ANA-8Pro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500432
Basic UDI-DI: B-04250289500432
Reference: 3101
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

AESKULISA® ANA-8S

AESKULISA® ANA-8S

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500425
Basic UDI-DI: B-04250289500425
Reference: 3100
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

Serazym® Nucleo ANA screen plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466110015
Basic UDI-DI: B-04099466110015
Reference: E-100
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

Serazym® Anti-dsDNA IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466105813
Basic UDI-DI: B-04099466105813
Reference: E-058
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:43

Manufacturer products View details

FA2500A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ZEUS Scientific
Manufacturer SRN: US-MF-000026845
UDI-DI: 00845533001892
Basic UDI-DI: B-00845533001892
Reference: FA2500A
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Mi-2

BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416836
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02274
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDiverDot ANA + DFS-70 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: 05425023681695
Basic UDI-DI: 542502368BDDANAYE
Reference: RLH12DIV-24
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 16.07.2026 09:59

Manufacturer products View details

Anti-dsDNA IgG Anti-double-stranded DNA IgG Antibody(CLIA)

Anti-dsDNA IgG Anti-double-stranded DNA IgG Antibody(CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-anti-dsDNA706-AEST
Basic UDI-DI: B-anti-dsDNA706-AEST
Reference: anti-dsDNA706-AE10Y, anti-dsDNA706-AE10N, anti-dsDNA706-AE20Y, anti-dsDNA706-AE20N
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

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

Anti-dsDNA Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4422253JK
Basic UDI-DI: B-IM4422253JK
Reference: IM4422253
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
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

Anti-PM-Scl Anitibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4415265K4
Basic UDI-DI: B-IM4415265K4
Reference: IM4415265
EMDN: W0102100109
EMDN description: PM-SCL - ANTIBODIES
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:34

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-histone Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4415264K2
Basic UDI-DI: B-IM4415264K2
Reference: IM4415264
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:34

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4415257K5
Basic UDI-DI: B-IM4415257K5
Reference: IM4415257
EMDN: W0102100112
EMDN description: SS-A
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:34

Manufacturer products Authorised representative products Authorised representative actors View details