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125 device results listed.

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Inﬂuenza B Antigen Rapid Test

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303193
Basic UDI-DI: B-06974566303193
Reference: RINb-8021
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Inﬂuenza B Antigen Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303186
Basic UDI-DI: B-06974566303186
Reference: RINb-80225
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Estonia
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Inﬂuenza B Antigen Rapid Test

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303179
Basic UDI-DI: B-06974566303179
Reference: RINb-8025
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Finland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302912
Basic UDI-DI: B-06974566302912
Reference: MRP-82220
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Antigen Rapid Test Device

5Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566301359
Basic UDI-DI: B-06974566301359
Reference: MSA-8025
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Antigen Rapid Test Device

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566301342
Basic UDI-DI: B-06974566301342
Reference: MSA-8021
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Antigen Rapid Test Device

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566301335
Basic UDI-DI: B-06974566301335
Reference: MSA-80220
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Bulgaria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238911169
Basic UDI-DI: B-06974238911169
Reference: HFLU015GA
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B Antigen Combo Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238911145
Basic UDI-DI: B-06974238911145
Reference: HFLU014GAB
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Rapid Test

K251316T

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792053304
Basic UDI-DI: B-06971792053304
Reference: K251316T
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

PreventID® Influenza A+B

IVD generalIVDDOn the marketKitNear-patient testingSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013377
Basic UDI-DI: B-04050598013377
Reference: KST50112GP
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:50

Manufacturer products View details

D-000041242IAB001-25YW

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242IAB001-25YW
Basic UDI-DI: B-000041242IAB001-25YW
Reference: IAB001-25
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-000041242IAB001-05YQ

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242IAB001-05YQ
Basic UDI-DI: B-000041242IAB001-05YQ
Reference: IAB001-05
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-000041242IAB001-01YG

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242IAB001-01YG
Basic UDI-DI: B-000041242IAB001-01YG
Reference: IAB001-01
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

06974689730784

Mycoplasma Pneumoniae Antigen Combo Test Cassette: 1 Test/Kit

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

Manufacturer: Beijing Zhongjian Antai Diagnostic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000052880
UDI-DI: 06974689730784
Basic UDI-DI: 697468973JT73V4
Reference: JT73
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Human Parainfluenza Virus IgM (CLIA)

Human Parainfluenza Virus IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547462
Basic UDI-DI: 69471455275WG
Reference: 130219025M
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Influenza A Virus IgM (CLIA)

Influenza A Virus IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547301
Basic UDI-DI: 69471455273WC
Reference: 130219023M
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Influenza A Virus IgM (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547349
Basic UDI-DI: 69471455273WC
Reference: 130619023M
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Influenza A Virus IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547363
Basic UDI-DI: 69471455273WC
Reference: 160201273MT
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Human Parainfluenza Virus IgM (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547509
Basic UDI-DI: 69471455275WG
Reference: 130619025M
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details