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Last updated

22.09.2026 08:45

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30 device results listed.

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LyoSens™

LYO68WS96

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276924
Basic UDI-DI: 868499827PCR68YB
Reference: LYO68WS96
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 06:16

Manufacturer products View details

06930317888104

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317888104
Basic UDI-DI: B-06930317888104
Reference: DNK-2107-1
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

06930317841994

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317841994
Basic UDI-DI: B-06930317841994
Reference: DNK-2510-1
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

06930317806924

24 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317806924
Basic UDI-DI: B-06930317806924
Reference: DNK-2603-1
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details

06930317806917

48 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317806917
Basic UDI-DI: B-06930317806917
Reference: DNK-2603-2
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 12:39

Manufacturer products Authorised representative products Authorised representative actors View details

04250592378544

eazyplex® Candida auris

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: AmplexDiagnostics GmbH
Manufacturer SRN: DE-MF-000014117
UDI-DI: 04250592378544
Basic UDI-DI: 42505923CAURJW
Reference: 7854
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:42

Manufacturer products View details

VIASURE Candida auris 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: 08435440258261
Basic UDI-DI: 84354402_MDXRESIST_CAUL3
Reference: VS-CAU101L
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

Candida auris ELITe MGB® Kit

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: ElitechGroup S.p.A.
Manufacturer SRN: IT-MF-000005919
UDI-DI: 08033891488598
Basic UDI-DI: 803389148CAU739M
Reference: RTS203ING
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 11:48

Manufacturer products View details

RevoDx Candida auris qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387210621
Basic UDI-DI: B-08684387210621
Reference: IP202307-500
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:47

Manufacturer products View details

RevoDx Candida auris qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387210614
Basic UDI-DI: B-08684387210614
Reference: IP202307-100
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:47

Manufacturer products View details

Candida auris - ELITe Positive Control

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: ElitechGroup S.p.A.
Manufacturer SRN: IT-MF-000005919
UDI-DI: 08033891488604
Basic UDI-DI: 803389148CAU739M
Reference: CTR203ING
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 07.07.2026 15:40

Manufacturer products View details

VIASURE Candida auris 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: 08435440258278
Basic UDI-DI: 84354402_MDXRESIST_CAUL3
Reference: VS-CAU101H
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 22:54

Manufacturer products View details

VIASURE Candida auris 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: 08435440258285
Basic UDI-DI: 84354402_MDXRESIST_CAUL3
Reference: VS-CAU106L
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 22:54

Manufacturer products View details

VIASURE Candida auris 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: 08435440258292
Basic UDI-DI: 84354402_MDXRESIST_CAUL3
Reference: VS-CAU106H
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 22:54

Manufacturer products View details

VIASURE Candida auris 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: 08435440258308
Basic UDI-DI: 84354402_MDXRESIST_CAUL3
Reference: VS-CAU112L
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 22:54

Manufacturer products View details

VIASURE Candida auris 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: 08435440258315
Basic UDI-DI: 84354402_MDXRESIST_CAUL3
Reference: VS-CAU112H
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 22:54

Manufacturer products View details

VIASURE Candida auris 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: 08435440258322
Basic UDI-DI: 84354402_MDXRESIST_CAUL3
Reference: VS-CAU113L
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 22:54

Manufacturer products View details

VIASURE Candida auris 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: 08435440258339
Basic UDI-DI: 84354402_MDXRESIST_CAUL3
Reference: VS-CAU113H
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 22:54

Manufacturer products View details

VIASURE Candida auris 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: 08435440258346
Basic UDI-DI: 84354402_MDXRESIST_CAUL3
Reference: VS-CAU196T
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 22:54

Manufacturer products View details

VIASURE Candida auris 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: 08435440260493
Basic UDI-DI: 84354402_MDXRESIST_CAUL3
Reference: VS-CAU101LE
EMDN: W0105060404
EMDN description: CANDIDA AURIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 06.07.2026 22:54

Manufacturer products View details