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MONO-VIDITEST anti-HHV-6 IgG

MONO-VIDITEST anti-HHV-6 IgG

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 18594036041605
Basic UDI-DI: B-18594036041605
Reference: K-160-12
EMDN: W0105040524
EMDN description: HHV-6,7,8 - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 10:25

Manufacturer products View details

SARS‐CoV‐2 Antigen Rapid Test Kit

SARS‐CoV‐2 Antigen Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Lvshiyuan Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000028164
UDI-DI: 16974169670057
Basic UDI-DI: B-16974169670057
Reference: 25 sets
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

SARS‐CoV‐2 Antigen Rapid Test Kit

SARS‐CoV‐2 Antigen Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Lvshiyuan Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000028164
UDI-DI: 16974169670040
Basic UDI-DI: B-16974169670040
Reference: 10 sets
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

EZER NAAT SARS-CoV-2 real-time RT-PCR Kit

N211102

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600750
Basic UDI-DI: B-16972698600750
Reference: N211102
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

EZER NAAT SARS-CoV-2 real-time RT-PCR Kit

N211101

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600743
Basic UDI-DI: B-16972698600743
Reference: N211101
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Flu Typing II Real Time PCR Detection Kit

-

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440222927
Basic UDI-DI: 84354402_MDXRESP_HXNZ2
Reference: VS-HXN101L
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:52

Manufacturer products View details

Truenat Influenza A/B

601200025

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139446
Basic UDI-DI: B-08908020139446
Reference: 601200025
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

601070025

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139064
Basic UDI-DI: B-08908020139064
Reference: 601070025
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat Influenza A/B

601200050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989668
Basic UDI-DI: B-08908007989668
Reference: 601200050
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat Influenza A/B

601200020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989651
Basic UDI-DI: B-08908007989651
Reference: 601200020
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat Influenza A/B

601200005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989644
Basic UDI-DI: B-08908007989644
Reference: 601200005, 601200020, 601200025, 601200050
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

601070020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989057
Basic UDI-DI: B-08908007989057
Reference: 601070020
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

601070005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989040
Basic UDI-DI: B-08908007989040
Reference: 601070005, 601070020, 601070025, 601070050
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

300186

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710797
Basic UDI-DI: B-08885019710797
Reference: 300186
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

300156

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710773
Basic UDI-DI: B-08885019710773
Reference: 300156
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

300185

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710735
Basic UDI-DI: B-08885019710735
Reference: 300185
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

300155

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710742
Basic UDI-DI: B-08885019710742
Reference: 300155
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

300107

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710711
Basic UDI-DI: B-08885019710711
Reference: 300107
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

300108

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710117
Basic UDI-DI: B-08885019710117
Reference: 300108
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

ViroKey SARS-CoV-2 RT-PCR Test

300680

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013956634
Basic UDI-DI: B-08885013956634
Reference: 300680
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details