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28 device results listed.

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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)

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

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

06974081870705

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

Real-time PCR Quantitative Analyzer

AccuRa Mini

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870484
Basic UDI-DI: 697408187AccuRaMiniM6
Reference: 080
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
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

Real-time PCR Quantitative Analyzer

AccuRa32

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870477
Basic UDI-DI: 697408187AccuRa32DJ
Reference: 052
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
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 Extraction Reagents(Magnetic Bead)

TM-36

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870323
Basic UDI-DI: 697408187R044JD
Reference: MTQ036
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
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 Extraction Reagents(Magnetic Bead)

T-16,T-32,T-48,T-64,T-96,T-200,T-960

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870316
Basic UDI-DI: 697408187MTQVT
Reference: MTQM064
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 15:25

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extractor

Singu32

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870293
Basic UDI-DI: 697408187Singu324W
Reference: 029
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:25

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extractor

Singu20

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870248
Basic UDI-DI: 697408187Singu204P
Reference: 043
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:25

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction Reagents(Magnetic Bead)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870330
Basic UDI-DI: 697408187R044JD
Reference: MTQB036
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 13:10

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction Reagents(Magnetic Bead)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870347
Basic UDI-DI: 697408187R044JD
Reference: MTQM036
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 13:10

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction Reagents(Magnetic Bead)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870514
Basic UDI-DI: 697408187MTQVT
Reference: MTQ064
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 13:10

Manufacturer products Authorised representative products Authorised representative actors View details