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AESKULISA® Histone-H2B

AESKULISA® Histone-H2B

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500739
Basic UDI-DI: B-04250289500739
Reference: 3153
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® Histone-H2A

AESKULISA® Histone-H2A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500722
Basic UDI-DI: B-04250289500722
Reference: 3152
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

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AESKULISA® Histone-H1

AESKULISA® Histone-H1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500715
Basic UDI-DI: B-04250289500715
Reference: 3151
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

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AESKULISA® ssDNA-G

AESKULISA® ssDNA-G

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500685
Basic UDI-DI: B-04250289500685
Reference: 3146
EMDN: W0102100106
EMDN description: SS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

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AESKULISA® Histone-C

AESKULISA® Histone-C

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500708
Basic UDI-DI: B-04250289500708
Reference: 3150
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® ssDNA-M

AESKULISA® ssDNA-M

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500692
Basic UDI-DI: B-04250289500692
Reference: 3147
EMDN: W0102100106
EMDN description: SS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® dsDNA-A

AESKULISA® dsDNA-A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500630
Basic UDI-DI: B-04250289500630
Reference: 3141
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® dsDNA-Check

AESKULISA® dsDNA-Check

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500623
Basic UDI-DI: B-04250289500623
Reference: 3140
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

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AESKULISA® Nucleo-h

AESKULISA® Nucleo-h

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500616
Basic UDI-DI: B-04250289500616
Reference: 3130
EMDN: W0102100117
EMDN description: NUCLEOSOME ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

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CELIAC DISEASE SCREENING TEST

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: 07640164860015
Basic UDI-DI: 764016486CE2H867
Reference: CE2H88000KIT01IT
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Italy
Safety summary (SSCP/SSP): New Celiac Test · Rev. 2025-01
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Anti-CL IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546966
Basic UDI-DI: 697015090000328HM
Reference: CMQ3503
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CL CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546867
Basic UDI-DI: 697015090000327HK
Reference: CMQ3403
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-GP1 IgM CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546768
Basic UDI-DI: 697015090000324HD
Reference: CMQ3203
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-β2-GP1 IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546669
Basic UDI-DI: 697015090000323HB
Reference: CMQ3103
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CL IgA CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359514972
Basic UDI-DI: 697015090000330H8
Reference: CMQ3710
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CL IgM CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359514866
Basic UDI-DI: 697015090000329HP
Reference: CMQ3610
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Cardiolipin IgG

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

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

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416423
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02198C
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Croatia
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

ANA (HEp-20-10) IIFT

FA 1522-R

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

Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG
Manufacturer SRN: DE-MF-000005296
UDI-DI: 04049016160311
Basic UDI-DI: 4049016FA1522RZ8
Reference: FA 1522-2005-R
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 21:17

Manufacturer products View details

IMMULITE 2000 Anti-TG Ab

IVDR_67_LLB_DUB-C_B_KIT_Anti-TG Ab

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962108
Basic UDI-DI: 0405686901369VV
Reference: 10381659
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Celiac IgA Disease Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040532
Basic UDI-DI: B-08430793040532
Reference: 724120
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details