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305 device results listed.

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06973316742916

1 Test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316742916
Basic UDI-DI: B-06973316742916
Reference: R411304
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:07

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 and Influenza A/B Virus Antigen Combined Detection Kit (Colloidal Gold-Based)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315730570
Basic UDI-DI: B-06973315730570
Reference: C9602CA
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

StrongStep® System Device for SARS-CoV-2,Influenza A/B & RSV Combo Antigen Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN: CN-MF-000041298
UDI-DI: 06973181850488
Basic UDI-DI: B-06973181850488
Reference: 500350
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

StrongStep® System Device for SARS-CoV-2 & Influenza A/ B Combo Antigen Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN: CN-MF-000041298
UDI-DI: 06973181850044
Basic UDI-DI: B-06973181850044
Reference: 500220
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Spain
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 16:52

Manufacturer products Authorised representative products Authorised representative actors View details

06972412618057

Respiratory Multiple Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618057
Basic UDI-DI: B-06972412618057
Reference: 303021901
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory 13 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)

MF-141-10

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348763053
Basic UDI-DI: B-06971348763053
Reference: MF-141
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory 13 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)

MF-141-1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348763046
Basic UDI-DI: B-06971348763046
Reference: MF-141
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory 9 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)

MF-140-10

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348763039
Basic UDI-DI: B-06971348763039
Reference: MF-140
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory 9 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)

MF-140-1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348763022
Basic UDI-DI: B-06971348763022
Reference: MF-140
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/RhV/PIV/Influenza A/B / RSV/ADV/hMPV/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)

MF-139-25

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348763008
Basic UDI-DI: B-06971348763008
Reference: MF-139
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/RhV/PIV/Influenza A/B / RSV/ADV/hMPV/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)

MF-139-1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762995
Basic UDI-DI: B-06971348762995
Reference: MF-139
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/RhV/PIV & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)

MF-130-1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762537
Basic UDI-DI: B-06971348762537
Reference: MF-130
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/RhV/PIV & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)

MF-130-25

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762544
Basic UDI-DI: B-06971348762544
Reference: MF-130
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)

MF-129-25

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762513
Basic UDI-DI: B-06971348762513
Reference: MF-129
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

06939663978484

ISIRA-9445

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663978484
Basic UDI-DI: B-06939663978484
Reference: ISIRA-9445
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOQUICK NoRotAdeno

Immunoquick NoRotAdeno

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03700531700413
Basic UDI-DI: B-03700531700413
Reference: 1150013
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 19:26

Manufacturer products View details

BIOSYNEX COMBO ADENO/ROTA BSS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678594378
Basic UDI-DI: B-03532678594378
Reference: SW40020
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:47

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX COMBO COVID-FLU BSS

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678592336
Basic UDI-DI: B-03532678592336
Reference: SW40008
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:46

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412617937
Basic UDI-DI: 0697241261IRS-552BJ
Reference: 303034701-01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 03.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618354
Basic UDI-DI: 0697241261IRS-552BJ
Reference: 303034701-05
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 03.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details