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341 device results listed.

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RevoDx Flu A&B / RSV / SARS-CoV-2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387210454
Basic UDI-DI: B-08684387210454
Reference: IP202011-500
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:47

Manufacturer products View details

RevoDx Flu A&B / RSV / SARS-CoV-2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387210447
Basic UDI-DI: B-08684387210447
Reference: IP202011-100
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:47

Manufacturer products View details

RevoDx Flu A&B / SARS-CoV-2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387210034
Basic UDI-DI: B-08684387210034
Reference: IP202010-100
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 01:46

Manufacturer products View details

06975578360303

HHV

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360303
Basic UDI-DI: B-06975578360303
Reference: 2000262
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

06975447582126

12 reactions/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447582126
Basic UDI-DI: B-06975447582126
Reference: 106-0057-01
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors 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

06975327120592

SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Test Card

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120592
Basic UDI-DI: B-06975327120592
Reference: RM1011702-10
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

06975327120196

Influenza A/Influenza B/RSV Nucleic Acid Test Card

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120196
Basic UDI-DI: B-06975327120196
Reference: RM1010402-10
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Pluslife SARS-CoV-2/Influenza A/Influenza B Card

SARS-CoV-2/Influenza A/Influenza B Nucleic Acid Test Card

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120189
Basic UDI-DI: B-06975327120189
Reference: RM1010302-10
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test Kit（Colloidal Gold）

25Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490022
Basic UDI-DI: B-06975068490022
Reference: CP044.B1
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

06974960210004

Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sanway Gene Tech. Inc.
Manufacturer SRN: CN-MF-000037912
UDI-DI: 06974960210004
Basic UDI-DI: B-06974960210004
Reference: C004E
EMDN: W0105070301
EMDN description: HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 21:07

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

Flu A Flu B+RSV+ ADV 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: 06974674893340
Basic UDI-DI: B-06974674893340
Reference: 18-02-0098
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
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