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371 device results listed.

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U-CardDx™ 200

6 Types of Diarrhea Pathogens Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289854047
Basic UDI-DI: B-06933289854047
Reference: WR90P0003
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Influenza A Virus, Influenza B Virus and Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870385
Basic UDI-DI: B-06974081870385
Reference: RTI001
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Combo Test

Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140242
Basic UDI-DI: B-06958982140242
Reference: AH50-20
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Estonia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 03664965001044
Basic UDI-DI: B-03664965001044
Reference: ISIN-525H
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Candida spp qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717783
Basic UDI-DI: B-08683079717783
Reference: IP202314-100
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:24

Manufacturer products View details

Adenovinus/RSV /influenza A+B Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277515672
Basic UDI-DI: B-06970277515672
Reference: IARI-535
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743397

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743397
Basic UDI-DI: B-06955792743397
Reference: S3344E-15
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792743380

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743380
Basic UDI-DI: B-06955792743380
Reference: S3344E-1
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735736

Masern virus, Rubella virus, and Mumps virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735736
Basic UDI-DI: B-06955792735736
Reference: S3279E-48
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735729

Masern virus, Rubella virus, and Mumps virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735729
Basic UDI-DI: B-06955792735729
Reference: S3279E-24
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735316

Astrovirus/Sapovirus/Enteric Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735316
Basic UDI-DI: B-06955792735316
Reference: S3218E-24
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735323

Astrovirus/Sapovirus/Enteric Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735323
Basic UDI-DI: B-06955792735323
Reference: S3218E-48
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732551

Measles and Rubella virus (MeV/RV) RNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732551
Basic UDI-DI: B-06955792732551
Reference: S3278E-48
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732544

Measles and Rubella virus (MeV/RV) RNA Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732544
Basic UDI-DI: B-06955792732544
Reference: S3278E-24
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732179

Influenza A/B Virus and Respiratory Syncytial Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732179
Basic UDI-DI: B-06955792732179
Reference: S3336E-48
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732162

Influenza A/B Virus and Respiratory Syncytial Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792732162
Basic UDI-DI: B-06955792732162
Reference: S3336E-24
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus and RSV Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983105200
Basic UDI-DI: B-06936983105200
Reference: IARC-525
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

06930317815155

48 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317815155
Basic UDI-DI: B-06930317815155
Reference: DNK-2512-1
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 12:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Flu/RSV Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570084
Basic UDI-DI: B-04719878570084
Reference: PCRAE0106
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

VitaSIRO solo SARS-CoV-2/Flu/RSV Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570527
Basic UDI-DI: B-04719878570527
Reference: PCRAD1102
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details