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57 device results listed.

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Influenza A/B virus Antigen Rapid Test Kit

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677691776
Basic UDI-DI: B-06974677691776
Reference: IS-MY-015-5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B virus Antigen Rapid Test Kit

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677691769
Basic UDI-DI: B-06974677691769
Reference: IS-MY-015-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677691714
Basic UDI-DI: B-06974677691714
Reference: IS-MY-010-50
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677691707
Basic UDI-DI: B-06974677691707
Reference: IS-MY-010-20
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit

5 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677691691
Basic UDI-DI: B-06974677691691
Reference: IS-MY-010-5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677691684
Basic UDI-DI: B-06974677691684
Reference: IS-MY-010-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690892
Basic UDI-DI: B-06974677690892
Reference: IS-FZ-020-50
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690823
Basic UDI-DI: B-06974677690823
Reference: IS-FZ-021-50
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

6-in-1 Respiratory Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690755
Basic UDI-DI: B-06974677690755
Reference: IS-FZ-019-50
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for 2019-nCoVIgM/lgG Antibody (Colloidal Gold)

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690335
Basic UDI-DI: B-06974677690335
Reference: ZC-MY-202-2
EMDN: W0105041104
EMDN description: CORONAVIRUS IGM
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for 2019-nCoVIgM/lgG Antibody (Colloidal Gold)

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690328
Basic UDI-DI: B-06974677690328
Reference: ZC-MY-202-1
EMDN: W0105041104
EMDN description: CORONAVIRUS IGM
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold)

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690311
Basic UDI-DI: B-06974677690311
Reference: ZC-MY-003-2
EMDN: W0105041102
EMDN description: CORONAVIRUS ANTIBODIES - TOTAL
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold)

20 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690304
Basic UDI-DI: B-06974677690304
Reference: ZC-MY-003-1
EMDN: W0105041102
EMDN description: CORONAVIRUS ANTIBODIES - TOTAL
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

96 tests/ kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690281
Basic UDI-DI: B-06974677690281
Reference: ZC-HX-201-3
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: PureMDR GmbH
Last updated: 06.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

50 tests/ kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690274
Basic UDI-DI: B-06974677690274
Reference: ZC-HX-201-2
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: PureMDR GmbH
Last updated: 06.07.2026 20:21

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction and purification kit

IVD Class ANot specifiedOn the market

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690410
Basic UDI-DI: 6974677690410J2
Reference: TQ-BG-001-50
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction and purification kit

IVD Class ANot specifiedOn the market

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690441
Basic UDI-DI: 6974677690441JD
Reference: TQ-BG-004-96D-96
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction and purification kit

IVD Class ANot specifiedOn the market

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677691097
Basic UDI-DI: 6974677691097JT
Reference: IS-TQ-009-96-1
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 16:45

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction and purification kit

IVD Class ANot specifiedOn the market

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677691103
Basic UDI-DI: 6974677691103HV
Reference: IS-TQ-009-96-2
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 16:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Purification Instrument

IVD Class ANot specifiedOn the market

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690397
Basic UDI-DI: 6974677690397K3
Reference: /
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 06:42

Manufacturer products Authorised representative products Authorised representative actors View details