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76 device results listed.

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Influenza A/B Rapid Test

GIFLU

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763019
Basic UDI-DI: B-06976202763019
Reference: GIFLU-722
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

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

GISFRA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762852
Basic UDI-DI: B-06976202762852
Reference: GISFRA-702H
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

RSV/Influenza A+B Combo Rapid Test

GIRF

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762838
Basic UDI-DI: B-06976202762838
Reference: GIRF-732
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

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

GISFR

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762845
Basic UDI-DI: B-06976202762845
Reference: GISFR-742
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Combo Test

GINRA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762807
Basic UDI-DI: B-06976202762807
Reference: GINRA-632
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus/Rotavirus/Adenovirus Combo Rapid Test

GINRA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762760
Basic UDI-DI: B-06976202762760
Reference: GINRA-632
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus/RSV/Influenza A+B Combo Rapid Test

GIARF

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762364
Basic UDI-DI: B-06976202762364
Reference: GIARF-742
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

06975578360150

P09

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360150
Basic UDI-DI: B-06975578360150
Reference: 2000244
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

06975578360143

MP02

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360143
Basic UDI-DI: B-06975578360143
Reference: 2000236
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

Comprehensive Pathogen NA Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Suzhou GenePlus Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000035774
UDI-DI: 06975352996230
Basic UDI-DI: B-06975352996230
Reference: 101122103
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Portugal
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

Meningitis/Encephalitis (ME) pathogens digital PCR detection kit

ME01-Y24

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689627299
Basic UDI-DI: B-06974689627299
Reference: 13699-2
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Meningitis/Encephalitis (ME) pathogens digital PCR detection kit

ME01-Q24

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689626568
Basic UDI-DI: B-06974689626568
Reference: 13699-1
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

Bacterial Vaginosis(BV) Test

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303957
Basic UDI-DI: B-06974566303957
Reference: BV01
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Belgium
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

Bacterial Vaginosis(BV) Test

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303940
Basic UDI-DI: B-06974566303940
Reference: BV20
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Greece
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogen 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: 06974566303773
Basic UDI-DI: B-06974566303773
Reference: RSA-0201
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Denmark
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogen 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: 06974566303766
Basic UDI-DI: B-06974566303766
Reference: RSA-02020
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogen Antigen Rapid Test

25Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303759
Basic UDI-DI: B-06974566303759
Reference: RSA-02025
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Greece
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:58

Manufacturer products Authorised representative products Authorised representative actors View details

Bacterial Vaginosis combo Test (H2O2 ,SA,LE,PH,CV,TV)

20Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303650
Basic UDI-DI: B-06974566303650
Reference: S0007-20
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Bacterial Vaginosis combo Test (H2O2 ,SA,LE,PH,CV,TV)

1Test/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303674
Basic UDI-DI: B-06974566303674
Reference: S0007-1
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Belgium
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Bacterial Vaginosis combo Test (H2O2 ,SA,LE,PH)

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303643
Basic UDI-DI: B-06974566303643
Reference: S0004
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Bulgaria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details