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

Last updated

22.09.2026 11:56

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70 device results listed.

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Eye Infection Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525017
Basic UDI-DI: 868521452PCR162GA
Reference: LYO162WS24
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 22.09.2026 09:58

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525055
Basic UDI-DI: 868521452PCR162GA
Reference: LYO162WS48
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:58

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525093
Basic UDI-DI: 868521452PCR162GA
Reference: LYO162WS96
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:58

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525956
Basic UDI-DI: 868521452PCR162GA
Reference: CFP162P25
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:58

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525963
Basic UDI-DI: 868521452PCR162GA
Reference: CFP162P50
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:58

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525970
Basic UDI-DI: 868521452PCR162GA
Reference: CFP162P100
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:58

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: 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: 22.09.2026 08:32

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: 22.09.2026 08:32

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: 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: 22.09.2026 08:32

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: 22.09.2026 08:32

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: 22.09.2026 08:32

Manufacturer products View details

Allplex™ Candidiasis Assay

AllplexA™ Candidiasis Assay

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100738
Basic UDI-DI: 924010SD98030LF
Reference: SD9803X
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Vaginitis screening Assay

Allplex™ Vaginitis screening Assay

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101186
Basic UDI-DI: 924010SD97500LQ
Reference: SD9750X
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Vaginitis screening Assay

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IVD Class CNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101575
Basic UDI-DI: 924010SD97500LQ
Reference: SD9750Y
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Bacterial Vaginosis plus Assay

Allplex™ Bacterial Vaginosis plus Assay

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101599
Basic UDI-DI: 924010SD10159GU
Reference: SD10159X
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Candidiasis Assay

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IVD Class BNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101780
Basic UDI-DI: 924010SD98030LF
Reference: SD10178Z
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:28

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Bacterial Vaginosis plus Assay

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IVD Class CNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103203
Basic UDI-DI: 924010SD10159GU
Reference: SD10320Z
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:28

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Vaginitis screening Assay

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IVD Class CNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103210
Basic UDI-DI: 924010SD97500LQ
Reference: SD10321Z
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:28

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733237
Basic UDI-DI: B-06955792733237
Reference: S3105E
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

48 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317815162
Basic UDI-DI: B-06930317815162
Reference: DNK-2511-1
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX 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