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124 device results listed.

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DermaGenius® 2.0 Complete Multiplex real-time PCR kit

PN-401

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: PathoNostics B.V.
Manufacturer SRN: NL-MF-000002705
UDI-DI: 08719326750934
Basic UDI-DI: 87193267509PN-401EQ
Reference: PN-401
EMDN: W0105060402
EMDN description: CANDIDA ALBICANS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

MucorGenius® Multiplex real-time PCR kit

PN-700

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoNostics B.V.
Manufacturer SRN: NL-MF-000002705
UDI-DI: 08719326750958
Basic UDI-DI: B-08719326750958
Reference: PN-700
EMDN: W0105060499
EMDN description: MYCOLOGY NA REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

AsperGenius® 2.0 Species Multiplex real-time PCR kit

PN-101

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoNostics B.V.
Manufacturer SRN: NL-MF-000002705
UDI-DI: 08719326750989
Basic UDI-DI: B-08719326750989
Reference: PN-101
EMDN: W0105060401
EMDN description: ASPERGILLUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

AsperGenius® 2.0 Resistance TR Multiplex real-time PCR kit

PN-201

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoNostics B.V.
Manufacturer SRN: NL-MF-000002705
UDI-DI: 08719326750996
Basic UDI-DI: B-08719326750996
Reference: PN-201
EMDN: W0105060401
EMDN description: ASPERGILLUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

GeneProof Aspergillus MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696303143
Basic UDI-DI: B-08595696303143
Reference: ASP/MC/038
EMDN: W0105060401
EMDN description: ASPERGILLUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 05.08.2026 14:50

Manufacturer products View details

GeneProof Aspergillus MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696303136
Basic UDI-DI: B-08595696303136
Reference: ASP/MC/190
EMDN: W0105060401
EMDN description: ASPERGILLUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 05.08.2026 14:50

Manufacturer products View details

06930317807839

48 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317807839
Basic UDI-DI: B-06930317807839
Reference: DNK-2604-2
EMDN: W0105060499
EMDN description: MYCOLOGY NA REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 05.08.2026 14:17

Manufacturer products Authorised representative products Authorised representative actors View details

06930317807822

24 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317807822
Basic UDI-DI: B-06930317807822
Reference: DNK-2605-1
EMDN: W0105060405
EMDN description: PNEUMOCYSTIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 05.08.2026 14:17

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens™

Candida Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525130
Basic UDI-DI: 868521452PCR163GC
Reference: LYO163WS24
EMDN: W0105060402
EMDN description: CANDIDA ALBICANS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 22:57

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525178
Basic UDI-DI: 868521452PCR163GC
Reference: LYO163WS48
EMDN: W0105060402
EMDN description: CANDIDA ALBICANS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:51

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525215
Basic UDI-DI: 868521452PCR163GC
Reference: LYO163WS96
EMDN: W0105060402
EMDN description: CANDIDA ALBICANS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:51

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214526205
Basic UDI-DI: 868521452PCR163GC
Reference: CFP163P25
EMDN: W0105060402
EMDN description: CANDIDA ALBICANS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:51

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214526212
Basic UDI-DI: 868521452PCR163GC
Reference: CFP163P50
EMDN: W0105060402
EMDN description: CANDIDA ALBICANS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:51

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214526229
Basic UDI-DI: 868521452PCR163GC
Reference: CFP163P100
EMDN: W0105060402
EMDN description: CANDIDA ALBICANS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 04.08.2026 22:51

Manufacturer products View details

RevoDx Cryptococcus neoformans/gattii qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717981
Basic UDI-DI: B-08683079717981
Reference: IP202257-100
EMDN: W0105060403
EMDN description: CRYPTOCOCCUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:25

Manufacturer products View details

06930317896543

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317896543
Basic UDI-DI: B-06930317896543
Reference: DNK-1417-1
EMDN: W0105060402
EMDN description: CANDIDA ALBICANS - 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

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

06930317829046

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317829046
Basic UDI-DI: B-06930317829046
Reference: DNK-2109-1
EMDN: W0105060405
EMDN description: PNEUMOCYSTIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

06930317824027

24 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317824027
Basic UDI-DI: B-06930317824027
Reference: DNK-2608-1
EMDN: W0105060499
EMDN description: MYCOLOGY NA REAGENTS - OTHER
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