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Active filter:Manufacturer SRN:CN-MF-000027278

14 device results listed.

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26974900600173

IPOCT-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 26974900600173
Basic UDI-DI: 697490060IPOCT-018K
Reference: IPOCT-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Release Reagent

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900602026
Basic UDI-DI: 697490060NARR-01RX
Reference: NARR-01
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 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Magnetic Bead Nucleic Acid Extraction Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900602019
Basic UDI-DI: 697490060NAEM-01LD
Reference: NAEM-01
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

16974900600183

MC42-P01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600183
Basic UDI-DI: 697490060MC42-P01GV
Reference: MC42-P01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

16974900600169

AutoPoc MDx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600169
Basic UDI-DI: 697490060AutoPocMDx2S
Reference: AutoPoc MDx
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Hand-held Nucleic Acid Detection Analyzer

SWSI-02

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600091
Basic UDI-DI: 697490060SWSI-0243
Reference: SWSI-02
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Microfluidic Chip

BS-C3-12

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600084
Basic UDI-DI: 697490060BS-C3-12HN
Reference: BS-C3-12
EMDN: W0503010280
EMDN description: SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Nucleic Acid Detection System

SWM-02

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600039
Basic UDI-DI: 697490060SWM-02PA
Reference: SWM-02
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

PCR Nucleic Acid Analyzer

SWM-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 06974900600018
Basic UDI-DI: 697490060SWM-01P8
Reference: SWM-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Hand-held Nucleic Acid Detection Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600114
Basic UDI-DI: 697490060SWSI-0243
Reference: SWAI-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Hand-held Nucleic Acid Detection Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600121
Basic UDI-DI: 697490060SWSI-0243
Reference: SWSI-03
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Hand-held Nucleic Acid Detection Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600138
Basic UDI-DI: 697490060SWSI-0243
Reference: SWSI-04
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Hand-held Nucleic Acid Detection Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600145
Basic UDI-DI: 697490060SWSI-0243
Reference: SWSI-05
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details

Hand-held Nucleic Acid Detection Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600244
Basic UDI-DI: 697490060SWSI-0243
Reference: MANO
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 17:51

Manufacturer products Authorised representative products Authorised representative actors View details