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01.08.2026 13:11

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135 device results listed.

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Truenat Dengue/Chikungunya

601040020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989361
Basic UDI-DI: B-08908007989361
Reference: 601040020
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - 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

Truenat Dengue/Chikungunya

601040005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989354
Basic UDI-DI: B-08908007989354
Reference: 601040005, 601040020, 601040025, 601040050
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - 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

08800204300218

RADI FAST Flu-SC2 Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300218
Basic UDI-DI: B-08800204300218
Reference: RV009F
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

SOFTEC SARS-CoV-2 Antigen Rapid Test Kit (Nasal Swab)

SFSCAGN1

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616312
Basic UDI-DI: B-08697962616312
Reference: ZET01N
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

RevoDx HBV/HCV Qualitative qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215145
Basic UDI-DI: B-08684387215145
Reference: IP202411-100
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx HBV/HCV Qualitative qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215138
Basic UDI-DI: B-08684387215138
Reference: IP202411-50
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

RevoDx HBV/HCV Qualitative qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215121
Basic UDI-DI: B-08684387215121
Reference: IP202411-25
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:03

Manufacturer products View details

VIUICK

Diagnostic Kit for Zika /Dengue /Chikungunya virus RNA (Real-Time PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Viuick Biotechnology Co.,LTD.
Manufacturer SRN: CN-MF-000017369
UDI-DI: 06975400320031
Basic UDI-DI: B-06975400320031
Reference: 48 Tests/Kit
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

06974795550610

60 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795550610
Basic UDI-DI: B-06974795550610
Reference: 10210122B
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details

06974795550603

10 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795550603
Basic UDI-DI: B-06974795550603
Reference: 10210122A
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details

06974795550511

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795550511
Basic UDI-DI: B-06974795550511
Reference: 10210120B
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details

06974795550504

10 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795550504
Basic UDI-DI: B-06974795550504
Reference: 10210120A
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:46

Manufacturer products Authorised representative products Authorised representative actors View details

06974795550399

10 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795550399
Basic UDI-DI: B-06974795550399
Reference: 10200145A
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

06974795550382

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795550382
Basic UDI-DI: B-06974795550382
Reference: 10200145B
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:44

Manufacturer products Authorised representative products Authorised representative actors View details

Flu AB + SARS-CoV-2 Antigen Rapid Detection Kit(Colloidal Gold)

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674893357
Basic UDI-DI: B-06974674893357
Reference: 18-02-0099
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

Coxsackie virus group A type 16 & enterovirus type 71 Diagnostic Kit (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892619
Basic UDI-DI: B-06974674892619
Reference: 18-01-0021
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

06974323018766

Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018766
Basic UDI-DI: B-06974323018766
Reference: CG9063
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

06974323018759

Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018759
Basic UDI-DI: B-06974323018759
Reference: CG9063
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

06974323018742

Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018742
Basic UDI-DI: B-06974323018742
Reference: CG9063
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

06974323018407

Influenza A / B / Parainfluenza virus Antigen Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018407
Basic UDI-DI: B-06974323018407
Reference: IH010
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:02

Manufacturer products Authorised representative products Authorised representative actors View details