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293 device results listed.

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Aptima Herpes Simplex Viruses 1 & 2 Assay Controls Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045507234
Basic UDI-DI: 54200455DIAGAPTHSV12S7
Reference: PRD-03569
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: -
Authorised representative: Hologic BV
Last updated: 29.06.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731646

Herpes Simplex Virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731646
Basic UDI-DI: B-06955792731646
Reference: S3028E
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:31

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Herpes Simplex Virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731639
Basic UDI-DI: B-06955792731639
Reference: S3028E
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:31

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06955792730779

Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730779
Basic UDI-DI: B-06955792730779
Reference: S3002E
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:28

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Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730762
Basic UDI-DI: B-06955792730762
Reference: S3002E
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:28

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MAGICL HSV-II IgM (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798869
Basic UDI-DI: B-06954414798869
Reference: /
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:34

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MAGICL HSV-II IgG (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798852
Basic UDI-DI: B-06954414798852
Reference: /
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:34

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MAGICL HSV-I IgM (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798845
Basic UDI-DI: B-06954414798845
Reference: /
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:34

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MAGICL HSV-I IgG (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798838
Basic UDI-DI: B-06954414798838
Reference: /
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:34

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VivaDiag Herpes Simplex Virus Type 1/2 IgG Test Kit (FIA)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339205179
Basic UDI-DI: B-06937339205179
Reference: VID135-01-011
EMDN: W0105040303
EMDN description: HSV 1+2 IGG
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:53

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VivaDiag Herpes Simplex Virus Type 1 IgM Test Kit (FIA)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339205162
Basic UDI-DI: B-06937339205162
Reference: VID134-01-011
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:53

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VivaDiag Herpes Simplex Virus Type 1 IgG Test Kit (FIA)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339205155
Basic UDI-DI: B-06937339205155
Reference: VID133-01-011
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:53

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iFlash-HSV-1 IgG

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718475
Basic UDI-DI: 692591270061H5
Reference: C88040G
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 14:12

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