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EUDAMED Device Search

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

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Q023A

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SML Genetree Co., Ltd.
Manufacturer SRN: KR-MF-000034755
UDI-DI: 08800087901519
Basic UDI-DI: 880008792023GIB3QB
Reference: Q023A-100
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: Obelis s.a.
Last updated: 11.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

Q022A

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SML Genetree Co., Ltd.
Manufacturer SRN: KR-MF-000034755
UDI-DI: 08800087901502
Basic UDI-DI: 880008792022GIB2PW
Reference: Q022A-100
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: Obelis s.a.
Last updated: 11.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

Q021A

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SML Genetree Co., Ltd.
Manufacturer SRN: KR-MF-000034755
UDI-DI: 08800087901496
Basic UDI-DI: 880008792021GIB1PH
Reference: Q021A-100
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: Obelis s.a.
Last updated: 11.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

GNT-2013-1

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SML Genetree Co., Ltd.
Manufacturer SRN: KR-MF-000034755
UDI-DI: 08800087901014
Basic UDI-DI: 88000879017SD
Reference: GNT-2013-1
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: Obelis s.a.
Last updated: 11.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

Q005A

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SML Genetree Co., Ltd.
Manufacturer SRN: KR-MF-000034755
UDI-DI: 08800087900628
Basic UDI-DI: 880008792018QSTVZ7
Reference: Q005A-100
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: Obelis s.a.
Last updated: 11.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275552
Basic UDI-DI: 868499827PCR55Y2
Reference: LYO55WS96
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 11.08.2026 00:07

Manufacturer products View details

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

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275521
Basic UDI-DI: 868499827PCR55Y2
Reference: LYO55WS48
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 11.08.2026 00:03

Manufacturer products View details

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

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595033562
Basic UDI-DI: 868499827PCR55Y2
Reference: CFP55P50
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 10.08.2026 23:58

Manufacturer products View details

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

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031933
Basic UDI-DI: 868499827PCR55Y2
Reference: CFP55P25
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 10.08.2026 23:54

Manufacturer products View details

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

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258977
Basic UDI-DI: 868499827PCR55Y2
Reference: LYO55WS24
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 10.08.2026 23:33

Manufacturer products View details

SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test

SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983169912
Basic UDI-DI: B-06936983169912
Reference: ISIN-525H
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 10.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805577
Basic UDI-DI: B-08685115805577
Reference: PCR54
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 10.08.2026 22:51

Manufacturer products View details

-

IVD generalIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805614
Basic UDI-DI: B-08685115805614
Reference: PCR54
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 10.08.2026 22:51

Manufacturer products View details

-

IVD generalIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031926
Basic UDI-DI: B-08684595031926
Reference: PCR54
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 10.08.2026 22:51

Manufacturer products View details

-

IVD generalIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595033555
Basic UDI-DI: B-08684595033555
Reference: PCR54
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 10.08.2026 22:51

Manufacturer products View details

CT/NG/MG Genotyping qPCR Kit

IVD generalIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257802
Basic UDI-DI: B-08683548257802
Reference: PCR54
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 10.08.2026 22:51

Manufacturer products View details

VIASURE Respiratory Viral Panel I Real Time PCR Detection Kit

VIASURE Respiratory Viral Panel I Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440205883
Basic UDI-DI: 84354402_MDXRESP_RPAZ2
Reference: VS-RPA106L
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 07.08.2026 23:10

Manufacturer products View details

VIASURE Respiratory Viral Panel I Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440222361
Basic UDI-DI: 84354402_MDXRESP_RPAZ2
Reference: VS-RPA101L
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 07.08.2026 22:46

Manufacturer products View details

VIASURE Respiratory Viral Panel I Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440222378
Basic UDI-DI: 84354402_MDXRESP_RPAZ2
Reference: VS-RPA101H
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 07.08.2026 22:46

Manufacturer products View details

VIASURE Respiratory Viral Panel I Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440205890
Basic UDI-DI: 84354402_MDXRESP_RPAZ2
Reference: VS-RPA106H
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 07.08.2026 22:46

Manufacturer products View details