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08800174502377

NGD961

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

Manufacturer: Genolution Inc.
Manufacturer SRN: KR-MF-000010391
UDI-DI: 08800174502377
Basic UDI-DI: 88001745-48N-R-NY
Reference: CVD231
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

08800174501905

JGD061

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

Manufacturer: Genolution Inc.
Manufacturer SRN: KR-MF-000010391
UDI-DI: 08800174501905
Basic UDI-DI: 88001745-JR-R-5N
Reference: FF131
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

RealAccurate® Quadruplex Influenza PCR Kit

PF0970-R

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: PathoFinder B.V.
Manufacturer SRN: NL-MF-000002704
UDI-DI: 08719326569901
Basic UDI-DI: 87193265699PF0970-R5M
Reference: PF0970-R
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 03.07.2026 19:35

Manufacturer products 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

Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT- PCR)

BSJ05S1, BSJ05M1, BSJ05L1

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227818
Basic UDI-DI: 697384322BSJ05JJ
Reference: BSJ05L1
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
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 RSV Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240206
Basic UDI-DI: 697349224U2020082B000G8
Reference: U20208
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - 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

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

04049095210587

RIDA®UNITY Viral Stool Panel IV