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FR166-Yellow Fever Virus -(Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430041
Basic UDI-DI: B-04262420430041
Reference: FR166
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:56

Manufacturer products View details

MutaPLEX BV-1 quant. (LAC/AV/GV)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598009318
Basic UDI-DI: B-04050598009318
Reference: KG197596
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:48

Manufacturer products View details

MutaPLEX STI-2 (TV/MH/UPU)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598009301
Basic UDI-DI: B-04050598009301
Reference: KG197296
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:48

Manufacturer products View details

MutaPLEX® Enterovirus, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002791
Basic UDI-DI: B-04050598002791
Reference: KG190232
EMDN: W0105040502
EMDN description: ENTEROVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:42

Manufacturer products View details

MutaPLEX® Norovirus, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002784
Basic UDI-DI: B-04050598002784
Reference: KG190132
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:42

Manufacturer products View details

MutaPLEX® Norovirus, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002500
Basic UDI-DI: B-04050598002500
Reference: KG190196
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:41

Manufacturer products View details

MutaPLEX® Enterovirus, PCR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598002418
Basic UDI-DI: B-04050598002418
Reference: KG190296
EMDN: W0105040502
EMDN description: ENTEROVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:41

Manufacturer products View details

04049095160448

RIDA®GENE Enterovirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095160448
Basic UDI-DI: B-04049095160448
Reference: PG4705
EMDN: W0105040502
EMDN description: ENTEROVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:06

Manufacturer products View details

IDTM SARS-CoV-2/Influenza Triplex

IDRESPI-P1-100 (FR) - Boîtes

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ID SOLUTIONS
Manufacturer SRN: FR-MF-000024876
UDI-DI: 03760367185037
Basic UDI-DI: B-03760367185037
Reference: IDRESPI-P1-100 (FR) - Boîtes
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:19

Manufacturer products View details

Fluxergy Reaction Mix COVID-19

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Fluxergy Inc.
Manufacturer SRN: US-MF-000010833
UDI-DI: 00850027856094
Basic UDI-DI: B-00850027856094
Reference: 4155-CE
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.07.2026 11:00

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

Monkeypox Virus Typing Nucleic Acid Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-00001280719907AT2
Basic UDI-DI: B-00001280719907AT2
Reference: HWTS-OT201
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus and Typing Nucleic Acid Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128072010E1NV
Basic UDI-DI: B-0000128072010E1NV
Reference: HWTS-OT202
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

Enterovirus Universal, EV71 and CoxA16 Nucleic Acid Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-00001280716908AS4
Basic UDI-DI: B-00001280716908AS4
Reference: HWTS-EV026
EMDN: W0105040502
EMDN description: ENTEROVIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIADVA00100I

NovaLisa® Adenovirus IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIADVA00100I
Basic UDI-DI: B-+ENTIADVA00100I
Reference: ADVA0010
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 04.07.2026 08:07

Manufacturer products View details

AccuPower® RV Kit (ExiStation™ FA 96)

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537078740
Basic UDI-DI: 880953707RVP3116ZP
Reference: RVP-3116
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537077866
Basic UDI-DI: 880953707NCVM21111JH
Reference: NCVM2-1111
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

IRON-qPCR™ RV Kit

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIONEER Corporation
Manufacturer SRN: KR-MF-000018672
UDI-DI: 08809537072533
Basic UDI-DI: 880953707QRV1113YY
Reference: QRV-1113
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:58

Manufacturer products Authorised representative products Authorised representative actors View details

08800174502933

DGD961

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

Manufacturer: Genolution Inc.
Manufacturer SRN: KR-MF-000010391
UDI-DI: 08800174502933
Basic UDI-DI: 88001745-DUO-R-6Z
Reference: DCF242
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