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37 device results listed.

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Detection Kit for Respiratory Syncytial Virus RNA (PCR Fluorescence Probing)

Detection Kit for Respiratory Syncytial Virus RNA (PCR Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870798
Basic UDI-DI: B-06974081870798
Reference: RSV001
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Human MTHFR Gene Polymorphism (PCR-Fluorescence Probing)

Detection Kit for Human MTHFR Gene Polymorphism (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870781
Basic UDI-DI: B-06974081870781
Reference: MTHFR
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

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Detection Kit for Monkeypox Virus(PCR Fluorescence Probing)

Detection Kit for Monkeypox Virus(PCR Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870774
Basic UDI-DI: B-06974081870774
Reference: MPV001
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit for Human Metapneumovirus (PCR-Fluorescence Probing)

Nucleic Acid Detection Kit for Human Metapneumovirus (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870767
Basic UDI-DI: B-06974081870767
Reference: HMPV001
EMDN: W0105040517
EMDN description: HUMAN METAPNEUMOVIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

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Detection Kit for 2019-nCOV,Influenza A Virus and Influenza B Virus（PCR Fluorescence Probe）

Detection Kit for 2019-nCOV,Influenza A Virus and Influenza B Virus（PCR Fluorescence Probe）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870422
Basic UDI-DI: B-06974081870422
Reference: CFP001
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

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Nucleic Acid Detection Kit for Seven respiratory pathogens (PCR-Fluorescence Probing)

Nucleic Acid Detection Kit for Seven respiratory pathogens (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870408
Basic UDI-DI: B-06974081870408
Reference: CFPD003
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

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

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

Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe)

Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870057
Basic UDI-DI: B-06974081870057
Reference: PCR001
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Test Kit (Colloidal Gold) (Cassette)

COVID-19 Antigen Test Kit (Colloidal Gold) (Cassette)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870040
Basic UDI-DI: B-06974081870040
Reference: NCAG
EMDN: W0105041103
EMDN description: CORONAVIRUS IGG
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:43

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Detection Kit for Dengue virus/Zika virus/ Chikungunya virus (PCR-Fluorescence Probing)

MBD001-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870439
Basic UDI-DI: B-06974081870439
Reference: MBD001-48
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit(PCR Fluorescent Probe Method)

TB002-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870415
Basic UDI-DI: B-06974081870415
Reference: TB002-48
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Plasmodium Falciparum (PCR Fluorescence Probing)

PF001-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870392
Basic UDI-DI: B-06974081870392
Reference: PF001-48
EMDN: W0105050309
EMDN description: PLASMODIUM (MALARIA) - NA REAGENTS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing)

HPV002-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870378
Basic UDI-DI: B-06974081870378
Reference: HPV002-48
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)

TB001-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870361
Basic UDI-DI: B-06974081870361
Reference: TB001-48
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Adenovirus Nucleic Acids (PCR-Fluorescence Probing)

ADV001-48

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870354
Basic UDI-DI: B-06974081870354
Reference: ADV001-48
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Detection Kit for High-risk Human Papillomavirus (PCR-Fluorescence Probing)

Nucleic Acid Detection Kit for High-risk Human Papillomavirus (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870309
Basic UDI-DI: B-06974081870309
Reference: HPV001
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:50

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

FluoreMini

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870736
Basic UDI-DI: 697408187FluoreMiniL4
Reference: FluoreMini
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:26

Manufacturer products Authorised representative products Authorised representative actors View details

Cell Preservation Solution

Cell Preservation Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870729
Basic UDI-DI: 697408187ACTSJ
Reference: BCY001
EMDN: W05020199
EMDN description: SAMPLES TRANSPORT, CONTAINERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:26

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable Virus Sampling Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870705
Basic UDI-DI: 697408187BCYSZ
Reference: BCY002
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:26

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Releaser (For PCR)

SR05050, SR10050, SR05080, SR10080,SR05100, SR10100, SR50001, SR100001, SR5L01, SR20L01

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870507
Basic UDI-DI: 697408187SR4D
Reference: SR10100
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:26

Manufacturer products Authorised representative products Authorised representative actors View details