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307 device results listed.

Page 14 / 16

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

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

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

-

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

-

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

-

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611508
Basic UDI-DI: 0697241261IRS-552BJ
Reference: 303034701-25
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

-

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618880
Basic UDI-DI: 0697241261IRS-552BJ
Reference: 303034701-40
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

Simple RSV-Flu A+B

9.081.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003245
Basic UDI-DI: 84295779081Y3
Reference: 9.081.020.47.000
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

COVID-19/RSV/Flu A+B Ag Rapid Test

P2081C01, P2081C02, P2081C05, P2081C20.

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230586
Basic UDI-DI: 697683823P208100FJ
Reference: P2081C01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Italy
Safety summary (SSCP/SSP): GS/TD-EU-P2081-1403 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test

SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277518697
Basic UDI-DI: B-06970277518697
Reference: ISIR-535
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Netherlands
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.06.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19&Influenza A/B&RSV&ADV&MP&HMPV&HPIV Antigen combo Test

Format (cassette): A4D83011 A4D830120 A4D830140 A4D83021 A4D830220 A4D830240

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804833060
Basic UDI-DI: 69528048A4D83007Q
Reference: A4D830
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19&Influenza A/B&RSV&ADV&MP&HMPV Antigen combo Test

Format (cassette): A4D73011 A4D730120 A4D730140 A4D73021 A4D730220 A4D730240

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804833022
Basic UDI-DI: 69528048A4D73007H
Reference: A4D730
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details