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

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01.08.2026 18:27

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36 device results listed.

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BK Virus R-GENE®

BK Virus R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026387761
Basic UDI-DI: 357302BUDI000441TC
Reference: 69-013B
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

Manufacturer products View details

VIASURE BK virus q Real Time PCR Detection Kit

VIASURE BK virus q Real Time PCR Detection Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440240068
Basic UDI-DI: 84354402_MDXIMMUN_BKQ66
Reference: VS-BKQ106L
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 22:54

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VIASURE BK virus q Real Time PCR Detection Kit

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440240075
Basic UDI-DI: 84354402_MDXIMMUN_BKQ66
Reference: VS-BKQ106H
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:39

Manufacturer products View details

VIASURE BK virus q Real Time PCR Detection Kit

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440240082
Basic UDI-DI: 84354402_MDXIMMUN_BKQ66
Reference: VS-BKQ112L
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:39

Manufacturer products View details

VIASURE BK virus q Real Time PCR Detection Kit

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440240099
Basic UDI-DI: 84354402_MDXIMMUN_BKQ66
Reference: VS-BKQ112H
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:39

Manufacturer products View details

VIASURE BK virus q Real Time PCR Detection Kit

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440240105
Basic UDI-DI: 84354402_MDXIMMUN_BKQ66
Reference: VS-BKQ113L
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:38

Manufacturer products View details

VIASURE BK virus q Real Time PCR Detection Kit

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440240112
Basic UDI-DI: 84354402_MDXIMMUN_BKQ66
Reference: VS-BKQ113H
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:38

Manufacturer products View details

VIASURE BK virus q Real Time PCR Detection Kit

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440240129
Basic UDI-DI: 84354402_MDXIMMUN_BKQ66
Reference: VS-BKQ196T
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:38

Manufacturer products View details

ALINITY M BKV

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999050655
Basic UDI-DI: 0884999AMN0985YB
Reference: 09N85-070
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

BK-Q Real Time PCR Kit for BK virus

G2M705421

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M705421FJ
Basic UDI-DI: B-G2M705421FJ
Reference: G2M705421,G2M705421R
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

EurobioPlex BK Virus

EurobioPlex BK Virus

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-015QD
Basic UDI-DI: B-EBX-015QD
Reference: EBX-015
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 18:32

Manufacturer products View details

EurobioPlex BK Virus

EurobioPlex BK Virus

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-015-48CG
Basic UDI-DI: B-EBX-015-48CG
Reference: EBX-015-48
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 18:32

Manufacturer products View details

EurobioPlex BK Virus

EurobioPlex BK Virus

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-015-24C2
Basic UDI-DI: B-EBX-015-24C2
Reference: EBX-015-24
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 18:32

Manufacturer products View details

Sentosa SA BKV Controls (8x3)

300633

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953756
Basic UDI-DI: B-08885013953756
Reference: 300633
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA BKV PCR Test (4X48)

300636

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953749
Basic UDI-DI: B-08885013953749
Reference: 300636
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA BKV Quantitation Controls (4x2)

300092

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953435
Basic UDI-DI: B-08885013953435
Reference: 300092
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA BKV Quantitation Standards (2x13)

300091

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953428
Basic UDI-DI: B-08885013953428
Reference: 300091
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA BKV PCR Test (4x24)

300088

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953411
Basic UDI-DI: B-08885013953411
Reference: 300088
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorion BKV QNP 1.0 Real-Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898740508
Basic UDI-DI: B-08698898740508
Reference: M0610202
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 14:59

Manufacturer products View details

LyoSens BKV qPCR Kit

LYO97WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115806093
Basic UDI-DI: B-08685115806093
Reference: LYO97
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:22

Manufacturer products View details