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06974858560563

Human Influenza Virus B Genotyping (Yamagata&Victoria) Nucleic Acid Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560563
Basic UDI-DI: B-06974858560563
Reference: P073H
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

06974858560235

Influenza A/B Virus RNA Detection Kit (Fluorescence PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Suzhou TianLong Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001080
UDI-DI: 06974858560235
Basic UDI-DI: B-06974858560235
Reference: P122H
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic Acid Detection Kit (Fluorescent RT-MIRA)

24 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677694630
Basic UDI-DI: B-06974677694630
Reference: IS-FZ-029-24-1
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA)

24 tests/kit Sampling tube with 2.5mL Lysis Buffer

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677694623
Basic UDI-DI: B-06974677694623
Reference: IS-FZ-034-24-2
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA)

24 tests/kit Sampling tube with 0.75mL Lysis Buffer

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677694616
Basic UDI-DI: B-06974677694616
Reference: IS-FZ-034-24-1
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

6-in-1 Respiratory Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690755
Basic UDI-DI: B-06974677690755
Reference: IS-FZ-019-50
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B virus 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: 06974674892527
Basic UDI-DI: B-06974674892527
Reference: 18-01-0012
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
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

Influenza A (H1N1) 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: 06974674892510
Basic UDI-DI: B-06974674892510
Reference: 18-01-0011
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
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

Sars-CoV-2 & Influenza A+B Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910056
Basic UDI-DI: B-06974238910056
Reference: HCOFLU021G
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

IFVA/H1N1/IFVB Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000017861
UDI-DI: 06971042225444
Basic UDI-DI: B-06971042225444
Reference: RR-0362-02
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

00840733101656

Immunocard STAT Flu A&B

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 00840733101656
Basic UDI-DI: B-00840733101656
Reference: 782030
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 05.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

00840733101649

Immunocard STAT Flu A&B Nasopharyngeal Wash/Aspirate accessory kit

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 00840733101649
Basic UDI-DI: B-00840733101649
Reference: 781130
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 05.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit (Fluorescence PCR)

HWTS-RT176A

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369595
Basic UDI-DI: 697484936W01050405V2
Reference: HWTS-RT176A
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)

BSJ04S1, BSJ04M1, BSJ04L1

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227917
Basic UDI-DI: 697384322BSJ04JG
Reference: BSJ04L1
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Greece
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT Rapid Flu Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240190
Basic UDI-DI: 697349224U2020062B000FE
Reference: U20206
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Paraflu Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509306
Basic UDI-DI: 54200455DIAGPFPARAFLURZ
Reference: PRD-04329
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Panther Fusion Flu A/B/RSV Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045509283
Basic UDI-DI: 54200455DIAGPFFLUABRSVWG
Reference: PRD-04328
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

04049095210143

RIDA®UNITY Parainfluenza

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210143
Basic UDI-DI: 4049095UN58050000UJ
Reference: UN5805
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

04049095210044

RIDA®UNITY Flu

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210044
Basic UDI-DI: 4049095UN05050000PY
Reference: UN0505
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:52

Manufacturer products View details

06970895476096

Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895476096
Basic UDI-DI: B-06970895476096
Reference: R083T010B0C1
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 30.06.2026 09:57

Manufacturer products Authorised representative products Authorised representative actors View details