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Human Metapneumovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731981
Basic UDI-DI: B-06955792731981
Reference: S3157E-48
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

Human Metapneumovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731974
Basic UDI-DI: B-06955792731974
Reference: S3157E-24
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Detection qPCR Kit

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983148832
Basic UDI-DI: B-06936983148832
Reference: IMX-P40
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

2019-nCoV/Flu/RSV Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849920
Basic UDI-DI: B-06933289849920
Reference: WR38P0006
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

2019-nCoV/Flu/RSV Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849913
Basic UDI-DI: B-06933289849913
Reference: WR38P0005
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

2019-nCoV/Flu/RSV Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289849906
Basic UDI-DI: B-06933289849906
Reference: WR38P0004
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Sweden
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

Fosun 2019-nCoV qPCR

Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Fosun Diagnostics (Shanghai) Co., Ltd.
Manufacturer SRN: CN-MF-000028169
UDI-DI: 06931654310075
Basic UDI-DI: B-06931654310075
Reference: PCSYHF02-e （48 tests/kit）
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details

Fosun 2019-nCoV qPCR

Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Fosun Diagnostics (Shanghai) Co., Ltd.
Manufacturer SRN: CN-MF-000028169
UDI-DI: 06931654310082
Basic UDI-DI: B-06931654310082
Reference: PCSYHF03-e
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details

06930317802094

25 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317802094
Basic UDI-DI: B-06930317802094
Reference: DNK-2115-1
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:37

Manufacturer products Authorised representative products Authorised representative actors View details

06930317801967

24 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317801967
Basic UDI-DI: B-06930317801967
Reference: DNK-1901-19
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06930317801875

50 tests

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317801875
Basic UDI-DI: B-06930317801875
Reference: DNK-2106-1
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06930317801868

50 tests

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317801868
Basic UDI-DI: B-06930317801868
Reference: DNK-1418-1
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

06928103014318

Large package, 48 tests/kit.

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103014318
Basic UDI-DI: B-06928103014318
Reference: DA1431
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06928103014301

Large package, 24 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103014301
Basic UDI-DI: B-06928103014301
Reference: DA1430
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06928103013915

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103013915
Basic UDI-DI: B-06928103013915
Reference: DA1391
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06928103013908

1 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103013908
Basic UDI-DI: B-06928103013908
Reference: DA1390
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06928103012215

Large package, 48 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103012215
Basic UDI-DI: B-06928103012215
Reference: DA1221
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06928103012208

Large package, 24 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103012208
Basic UDI-DI: B-06928103012208
Reference: DA1220
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

06928103011713

Large package, 96 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103011713
Basic UDI-DI: B-06928103011713
Reference: DA1171
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

06928103011706

Large package, 48 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103011706
Basic UDI-DI: B-06928103011706
Reference: DA1170
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 03.08.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details