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75 device results listed.

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Sentosa SA HSV1/2 PCR Test (4x48)

300671

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953671
Basic UDI-DI: B-08885013953671
Reference: 300671
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA HSV1/2 Quantitation Standards (2x13)

300071

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953305
Basic UDI-DI: B-08885013953305
Reference: 300071
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA HSV1/2 Quantitation Controls (4x2)

300072

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953251
Basic UDI-DI: B-08885013953251
Reference: 300072
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA HSV1/2 PCR Test (4x24)

300233

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953237
Basic UDI-DI: B-08885013953237
Reference: 300233
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

ChainFor HSV-6 Detection qPCR Kit

CFP115

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034873
Basic UDI-DI: B-08684595034873
Reference: CFP114
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:16

Manufacturer products View details

RevoDx HSV-2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213516
Basic UDI-DI: B-08684387213516
Reference: IP202233-25
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:57

Manufacturer products View details

RevoDx HSV-1 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213509
Basic UDI-DI: B-08684387213509
Reference: IP202232-25
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:57

Manufacturer products View details

LyoSens Genital Ulcer Genotyping qPCR Kit

LYO55

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548259769
Basic UDI-DI: B-08683548259769
Reference: LYO55
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:21

Manufacturer products View details

TaqPath™ Menu | GeneProof™ Herpes Simplex Virus (HSV-1/2) PCR Kit

GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696304065
Basic UDI-DI: B-08595696304065
Reference: A58128
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:59

Manufacturer products View details

GeneProof Herpes Simplex Virus (HSV-1/2) MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301156
Basic UDI-DI: B-08595696301156
Reference: HSV/MC/205
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:58

Manufacturer products View details

GeneProof Herpes Simplex Virus (HSV-1/2) MC PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696301149
Basic UDI-DI: B-08595696301149
Reference: HSV/MC/041
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:58

Manufacturer products View details

HSV1 DNA Quantitation (QT)

HSV1DNAQT.CE

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
Manufacturer SRN: IT-MF-000029123
UDI-DI: 08050616041708
Basic UDI-DI: B-08050616041708
Reference: HSV1DNAQT.CE
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:10

Manufacturer products View details

VIUICK

Diagnostic Kit for Herpes simplex virus type 1/2 DNA (Real-Time PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Viuick Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000017369
UDI-DI: 06975400320130
Basic UDI-DI: B-06975400320130
Reference: 48 Tests/Kit
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:31

Manufacturer products Authorised representative products Authorised representative actors View details

06974858560280

Herpes Simplex Virus (HSV) II Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560280
Basic UDI-DI: B-06974858560280
Reference: P176H
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

06974858560150

Herpes Simplex Virus (HSV) II Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560150
Basic UDI-DI: B-06974858560150
Reference: P106H
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ LyocartE HSV-1&HSV-2 Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767391999
Basic UDI-DI: B-06974767391999
Reference: 6018012202-CE
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FlashDetect™ LyocartE HSV-1&HSV-2 Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06974767390756
Basic UDI-DI: B-06974767390756
Reference: 6018012205-CE
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:41

Manufacturer products Authorised representative products Authorised representative actors View details

VZV/HSV2/HSV1 Multiplex Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229497
Basic UDI-DI: B-06971042229497
Reference: SD-0314-02
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

HSVI&II Typing Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229442
Basic UDI-DI: B-06971042229442
Reference: SD-0136-02
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

HSVⅠ&Ⅱ Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042229411
Basic UDI-DI: B-06971042229411
Reference: SD-0017-02
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details