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44 device results listed.

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AESKULISA® Herpes Simplex Virus 2 (gG2) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510424
Basic UDI-DI: B-04250289510424
Reference: 6048
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:23

Manufacturer products View details

SmarLumi

Herpes simplex virus-2 lgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859554
Basic UDI-DI: B-06933289859554
Reference: WA92P0003
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 07:03

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Herpes simplex virus-2 lgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859561
Basic UDI-DI: B-06933289859561
Reference: WA92P0004
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Herpes simplex virus-2 lgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859547
Basic UDI-DI: B-06933289859547
Reference: WA92P0002
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Herpes simplex virus-2 lgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289859530
Basic UDI-DI: B-06933289859530
Reference: WA92P0001
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

1×100 test/kit R1:1×2mL; R2:1×2.5mL; R3:1×2.5mL Calibrator High value:1×1mL; Calibrator Low value:1×1mL Control Level 1:1×1mL Control Level 2: 1×1mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794574442
Basic UDI-DI: B-06925794574442
Reference: 1×100 test/kit etc
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:38

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

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

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

D-R1921436

200 Tests/Kit