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01.08.2026 16:25

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24 device results listed.

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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

iFlash-HSV-1 IgM

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

Herpes simplex Virus 1 (HSV 1) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIRE579110H
Basic UDI-DI: B-+ENTIRE579110H
Reference: RE57911
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:18

Manufacturer products View details

+ENTIHSV1M05000E

NovaLisa® Herpes simplex Virus 1 (HSV 1) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHSV1M05000E
Basic UDI-DI: B-+ENTIHSV1M05000E
Reference: HSV1M0500
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIHSV1M050DS0C

NovaLisa® Herpes simplex Virus 1 (HSV 1) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHSV1M050DS0C
Basic UDI-DI: B-+ENTIHSV1M050DS0C
Reference: HSV1M050DS
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIEIA-419709

Herpes Simplex Virus 1 IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIEIA-419709
Basic UDI-DI: B-+ENTIEIA-419709
Reference: EIA-4197
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:13

Manufacturer products View details

+ENTIDEHSV1M05000+

Herpes simplex Virus 1 (HSV 1) IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDEHSV1M05000+
Basic UDI-DI: B-+ENTIDEHSV1M05000+
Reference: DEHSV1M0500
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

HSV-1 IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4423123JC
Basic UDI-DI: B-IM4423123JC
Reference: IM4423123
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1 IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4422123J5
Basic UDI-DI: B-IM4422123J5
Reference: IM4422123
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1 IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4418123K4
Basic UDI-DI: B-IM4418123K4
Reference: IM4418123
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1 IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4419123KB
Basic UDI-DI: B-IM4419123KB
Reference: IM4419123
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-HSV-1 IgM

-

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912719007
Basic UDI-DI: 692591270062H7
Reference: C88041M
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-HSV-1 IgM

-

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723554
Basic UDI-DI: 692591270062H7
Reference: C88041M-S
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ HSV-1 IgG/IgM Rapid Test Kit

VMD102

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030448
Basic UDI-DI: B-08684595030448
Reference: VMD102
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:13

Manufacturer products View details

HSV-1 IgM CLIA Microparticles

-

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552264
Basic UDI-DI: 697015090000102GR
Reference: CMK0405
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-I IgM (eCLIA)

2×100T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139070277
Basic UDI-DI: B-06978139070277
Reference: 0320512604
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-I IgM (eCLIA)

100T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139070260
Basic UDI-DI: B-06978139070260
Reference: 0320512603
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-I IgM (eCLIA)

2×50T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139070253
Basic UDI-DI: B-06978139070253
Reference: 0320512602
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-I IgM (eCLIA)

50T

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139070246
Basic UDI-DI: B-06978139070246
Reference: 0320512601
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus -Ⅰ IgM (HSV-Ⅰ IgM) Assay Reagent Kit (CMIA)

C2KE005

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753478110
Basic UDI-DI: B-06976753478110
Reference: C2KE005
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:01

Manufacturer products Authorised representative products Authorised representative actors View details