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Active filter:EMDN:W0105070501

219 device results listed.

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Step 2 Plates for Urinogenital (8-well)

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002212
Basic UDI-DI: B-09343044002212
Reference: 27113P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Step 1 tubes for STI (16-well)

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002120
Basic UDI-DI: B-09343044002120
Reference: 27112S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Step 2 Plates for STI (16-well)

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002113
Basic UDI-DI: B-09343044002113
Reference: 27112P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

08809446081879

MST-N05082

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: WELLS BIO, INC.
Manufacturer SRN: KR-MF-000031789
UDI-DI: 08809446081879
Basic UDI-DI: B-08809446081879
Reference: MST-N05082
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Greece
Authorised representative: MDSS GmbH
Last updated: 10.07.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

08809446080636

MST-N10082

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: WELLS BIO, INC.
Manufacturer SRN: KR-MF-000031789
UDI-DI: 08809446080636
Basic UDI-DI: B-08809446080636
Reference: MST-N10082
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Greece
Authorised representative: MDSS GmbH
Last updated: 10.07.2026 14:09

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II STI-7e Detection

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103234
Basic UDI-DI: B-08809240103234
Reference: SD10323Z
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:45

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II STI-7e Detection

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100301
Basic UDI-DI: B-08809240100301
Reference: SD7701X
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Anyplex™ II STI-7e Detection

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100295
Basic UDI-DI: B-08809240100295
Reference: SD7701Y
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFinder STDI( CT/NG/UU) Multiplex Real-time PCR kit

IFMR-03

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115905154
Basic UDI-DI: B-08809115905154
Reference: IFMR-03
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

PowerChek™ STI Multiplex Real-time PCR Kit Ⅲ

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056319024
Basic UDI-DI: B-08800056319024
Reference: CQ19TTO0003Z
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

PowerChek™ STI Multiplex Real-time PCR KitⅡ

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056319017
Basic UDI-DI: B-08800056319017
Reference: CQ19TTO0002Z
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens HSV-1/HSV-2/TP qPCR Kit

LYO128WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115804884
Basic UDI-DI: B-08685115804884
Reference: LYO128
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:22

Manufacturer products View details

RevoDx STI-6 Pathogen Detection Kit