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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

Allplex™ Candidiasis Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240005576
Basic UDI-DI: B-08809240005576
Reference: SD9803Y
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - 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

08800204300232

RADI FAST Flu-SC2-RSV Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300232
Basic UDI-DI: B-08800204300232
Reference: RV013F
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

08800204300218

RADI FAST Flu-SC2 Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300218
Basic UDI-DI: B-08800204300218
Reference: RV009F
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

ChainFor™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595033302
Basic UDI-DI: 868511580PCR28JG
Reference: CFP28P50
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 10.07.2026 03:38

Manufacturer products View details

PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit