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AESKUSLIDES® IFA NEGATIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289513050
Basic UDI-DI: B-04250289513050
Reference: NCIFA
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKUSLIDES® CONJUGATE ANA HEp-2

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289513043
Basic UDI-DI: B-04250289513043
Reference: C51.101.BULK
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKUSLIDES® CONJUGATE ANA HEp-2

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289513036
Basic UDI-DI: B-04250289513036
Reference: C51.101
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKUSLIDES® CONJUGATE ANA HEp-2

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289513029
Basic UDI-DI: B-04250289513029
Reference: C51.100.BULK
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKUSLIDES® CONJUGATE ANA HEp-2

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289513012
Basic UDI-DI: B-04250289513012
Reference: C51.100
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKUSLIDES® ANA PATTERN CONTROL (Homogeneous)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289512947
Basic UDI-DI: B-04250289512947
Reference: PC51.100
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKUSLIDES® MOUNTING MEDIUM

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289512930
Basic UDI-DI: B-04250289512930
Reference: MMIFA
EMDN: W01021499
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKUSLIDES® COUNTERSTAIN (Evans Blue 0.2%)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289512916
Basic UDI-DI: B-04250289512916
Reference: EBIFA
EMDN: W0103010301
EMDN description: HISTO / CYTO STAINS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKULISA® Clostridium tetani IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289511582
Basic UDI-DI: B-04250289511582
Reference: 6102
EMDN: W0105011609
EMDN description: TETANUS (CLOSTRIDIUM T.) - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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ChainFor™

Vaginosis ID-20 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032909
Basic UDI-DI: 868511580PCR118GN
Reference: CFP118P50
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 22.09.2026 11:23

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ChainFor™

CFP14

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257208
Basic UDI-DI: 868511580PCR118GN
Reference: CFP118P100
EMDN: W0105070201
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKULISA® Herpes Simplex Virus 1/2 IgM

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510653
Basic UDI-DI: B-04250289510653
Reference: 6043
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKULISA® Herpes Simplex Virus 1/2 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510646
Basic UDI-DI: B-04250289510646
Reference: 6042
EMDN: W0105040303
EMDN description: HSV 1+2 IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKULISA® Herpes Simplex Virus 2 (gG2) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510424
Basic UDI-DI: B-04250289510424
Reference: 6048
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKULISA® Herpes Simplex Virus 1 (gG1) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510417
Basic UDI-DI: B-04250289510417
Reference: 6045
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKULISA® Varicella-Zoster Virus IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510127
Basic UDI-DI: B-04250289510127
Reference: 6053
EMDN: W0105040903
EMDN description: VARICELLA ZOSTER VIRUS IGM
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

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AESKULISA® Varicella-Zoster Virus IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510110
Basic UDI-DI: B-04250289510110
Reference: 6052
EMDN: W0105040902
EMDN description: VARICELLA ZOSTER VIRUS IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

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AESKULISA® Varicella-Zoster Virus IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510103
Basic UDI-DI: B-04250289510103
Reference: 6051
EMDN: W0105040999
EMDN description: VARICELLA ZOSTER VIRUS REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

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AESKULISA® Parvovirus B19 IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510011
Basic UDI-DI: B-04250289510011
Reference: 6063
EMDN: W0105040509
EMDN description: PARVOVIRUS B 19 - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

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AESKULISA® Parvovirus B19 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510004
Basic UDI-DI: B-04250289510004
Reference: 6062
EMDN: W0105040509
EMDN description: PARVOVIRUS B 19 - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

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