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293 device results listed.

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LyoSens™

VZV qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115806796
Basic UDI-DI: 868511580PCR138GU
Reference: LYO138WS96
EMDN: W0105040399
EMDN description: HSV REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:29

Manufacturer products View details

ChainFor™

HSV-1/HSV-2 Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595035832
Basic UDI-DI: 868511580PCR139GW
Reference: CFP139P25
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:29

Manufacturer products View details

ChainFor™

HSV-1 qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034811
Basic UDI-DI: 868511580PCR140GF
Reference: CFP140P100
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:28

Manufacturer products View details

HERPES SIMPLEX 1+2 VIRCLIA® IgM MONOTEST

VCM036

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040326343
Basic UDI-DI: 843604032VCM03601CQ
Reference: VCM036
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

HSV-2 IgM CLIA Microparticles

Autolumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552349
Basic UDI-DI: 697015090000103GT
Reference: CMK0503
EMDN: W0105040310
EMDN description: HSV 2 IGM
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-2 IgG CLIA Microparticles

Autolumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552295
Basic UDI-DI: 697015090000108H5
Reference: CMK1003
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1 IgM CLIA Microparticles

Autolumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552240
Basic UDI-DI: 697015090000102GR
Reference: CMK0403
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1 IgG CLIA Microparticles

Autolumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552196
Basic UDI-DI: 697015090000107H3
Reference: CMK0903
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus-1 IgG（CLIA）

105-012500-00、105-012501-00、105-012503-00、105-012504-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039574
Basic UDI-DI: 69449040AB740001159
Reference: 105-012503-00
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus 1+2 IgG（CLIA）

105-012494-00、105-012495-00、105-012497-00、105-012498-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039550
Basic UDI-DI: 69449040AB74000135D
Reference: 105-012498-00
EMDN: W0105040303
EMDN description: HSV 1+2 IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus-2 IgG（CLIA）

105-012506-00 、105-012507-00、105-012509-00、105-012510-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039529
Basic UDI-DI: 69449040AB74000125B
Reference: 105-012509-00
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus 1+2 IgM（CLIA）

105-012488-00、105-012489-00、105-012491-00、105-012492-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039512
Basic UDI-DI: 69449040AB74000145F
Reference: 105-012489-00
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-HSV-1 IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715597
Basic UDI-DI: 692591270062H7
Reference: C88041M-L
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-HSV-2 IgM

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715580
Basic UDI-DI: 692591270060H3
Reference: C88039M-L
EMDN: W0105040310
EMDN description: HSV 2 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-HSV-2 IgG

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715573
Basic UDI-DI: 692591270059HJ
Reference: C88038G-L
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-HSV-1 IgG

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715344
Basic UDI-DI: 692591270061H5
Reference: C88040G-L
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPE 1 and 2

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384503827
Basic UDI-DI: 5032384ImagenHSVVJ
Reference: K610611-2
EMDN: W0105040301
EMDN description: HSV ANTIGEN
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX HERPES TYPING KIT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080500003
Basic UDI-DI: 50560805PathoDXHerpesW5
Reference: R62250
EMDN: W0105040301
EMDN description: HSV ANTIGEN
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115806710
Basic UDI-DI: 868511580PCR138GU
Reference: LYO138WS24
EMDN: W0105040399
EMDN description: VARICELLA ZOSTER - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:58

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115806758
Basic UDI-DI: 868511580PCR138GU
Reference: LYO138WS48
EMDN: W0105040399
EMDN description: VARICELLA ZOSTER - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 22:58

Manufacturer products View details