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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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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

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

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

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

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

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

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

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

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

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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AESKULISA® Borrelia-M

AESKULISA® Borrelia-M

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289501705
Basic UDI-DI: B-04250289501705
Reference: 3803
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

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AESKULISA® Borrelia-G

AESKULISA® Borrelia-G

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289501699
Basic UDI-DI: B-04250289501699
Reference: 3802
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

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SeraSpot® Anti-EBV-4 IgG

SeraSpot® Anti-EBV-4 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301352
Basic UDI-DI: B-04099466301352
Reference: SP-013-4 G-S12
EMDN: W010504040102
EMDN description: EBV IGG - TOTAL
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:21

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SeraSpot® Anti-EBV-4 IgG

SeraSpot® Anti-EBV-4 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301345
Basic UDI-DI: B-04099466301345
Reference: SP-013-4 G-S6
EMDN: W010504040102
EMDN description: EBV IGG - TOTAL
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:21

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SeraSpot® Anti-Parvovirus-6 IgG

SeraSpot® Anti-Parvovirus-6 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301253
Basic UDI-DI: B-04099466301253
Reference: SP-012-6 G-S12
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:21

Manufacturer products View details

SeraSpot® Anti-Parvovirus-6 IgG

SeraSpot® Anti-Parvovirus-6 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301246
Basic UDI-DI: B-04099466301246
Reference: SP-012-6 G-S6
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:21

Manufacturer products View details

SeraSpot® Anti-Parvovirus-5 IgM

SeraSpot® Anti-Parvovirus-5 IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301222
Basic UDI-DI: B-04099466301222
Reference: SP-012-5 M-S12
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:21

Manufacturer products View details

SeraSpot® Anti-Parvovirus-5 IgM

SeraSpot® Anti-Parvovirus-5 IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301215
Basic UDI-DI: B-04099466301215
Reference: SP-012-5 M-S6
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:21

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SeraSpot® Anti-Treponema-4 IgG

SeraSpot® Anti-Treponema-4 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301055
Basic UDI-DI: B-04099466301055
Reference: SP-010-4 G-S12
EMDN: W0105010303
EMDN description: SYPHILIS ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:21

Manufacturer products View details

SeraSpot® Anti-Treponema-4 IgG

SeraSpot® Anti-Treponema-4 IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466301048
Basic UDI-DI: B-04099466301048
Reference: SP-010-4 G-S6
EMDN: W0105010303
EMDN description: SYPHILIS ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:21

Manufacturer products View details