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39 device results listed.

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D-IM4410126HJ

HSV-1/2 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-IM4410126HJ
Basic UDI-DI: B-IM4410126HJ
Reference: IM4410126
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

HSV IgM Rapid Test Cassette (Whole blood/Serum/Plasma)

GCHSV(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHSV(IgM)-402aX7
Basic UDI-DI: B-GCHSV(IgM)-402aX7
Reference: GCHSV(IgM)-402a
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

HSV IgM Rapid Test Cassette (Whole blood/Serum/Plasma)

GCHSV(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHSV(IgM)-402aHGGF
Basic UDI-DI: B-GCHSV(IgM)-402aHGGF
Reference: GCHSV(IgM)-402a
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

HSV IgM Rapid Test Cassette (Serum/Plasma)

GCHSV(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHSV(IgM)-302aWY
Basic UDI-DI: B-GCHSV(IgM)-302aWY
Reference: GCHSV(IgM)-302a
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

HSV IgM Rapid Test Cassette (Serum/Plasma)

GCHSV(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHSV(IgM)-302aHGG2
Basic UDI-DI: B-GCHSV(IgM)-302aHGG2
Reference: GCHSV(IgM)-302a
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4205332FM

HSV-1/2 IgM

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4205332FM
Basic UDI-DI: B-EIM4205332FM
Reference: EIM4205332
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4202332EY

HSV-1/2 IgM

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4202332EY
Basic UDI-DI: B-EIM4202332EY
Reference: EIM4202332
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4201332ER

HSV-1/2 IgM

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4201332ER
Basic UDI-DI: B-EIM4201332ER
Reference: EIM4201332
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

MONO-VIDITEST anti-HSV 1+2 IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036041418
Basic UDI-DI: B-38594036041418
Reference: KZ-141-12
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

Manufacturer products View details

ELISA-VIDITEST anti-HSV 1+2 IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036042340
Basic UDI-DI: B-28594036042340
Reference: ODZ-234
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:21

Manufacturer products View details

MONO-VIDITEST anti-HSV 1+2 IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 18594036041414
Basic UDI-DI: B-18594036041414
Reference: K-141-12
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

Manufacturer products View details

ELISA-VIDITEST anti-HSV 1+2 IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 08594036042346
Basic UDI-DI: B-08594036042346
Reference: OD-234
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Czechia
Authorised representative: -
Last updated: 08.07.2026 01:43

Manufacturer products View details

Casete de Test Rápido de VHS 1/2 IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 08436592551422
Basic UDI-DI: B-08436592551422
Reference: ISM-302
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 08.07.2026 00:51

Manufacturer products Authorised representative products Authorised representative actors View details

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

C2KE004

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753478073
Basic UDI-DI: B-06976753478073
Reference: C2KE004
EMDN: W0105040304
EMDN description: HSV 1+2 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

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

C2KL010

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053694
Basic UDI-DI: B-06971792053694
Reference: C2KL010
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

CHORUS HERPES SIMPLEX 1+2 IgM

CHORUSHSM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322229
Basic UDI-DI: 803389132CHORUSHSM009Z
Reference: 81021
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products View details

Herpes Simplex Virus 1+2 IgM（CLIA）

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039543
Basic UDI-DI: 69449040AB74000145F
Reference: 105-012492-00
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus 1+2 IgM（CLIA）

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039567
Basic UDI-DI: 69449040AB74000145F
Reference: 105-012488-00
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus 1+2 IgM（CLIA）

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039611
Basic UDI-DI: 69449040AB74000145F
Reference: 105-012491-00
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details