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Full-Automatic Nucleic Acid Extraction and qPCR Analysis System

MW-1600BL

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou Molarray Co., Ltd
Manufacturer SRN: CN-MF-000053786
UDI-DI: 06975275770023
Basic UDI-DI: 697527577002NX
Reference: MW-1600BL
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 02.07.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Amplification Detection Analyzer

SmartRangerⅡ, SmartRangeⅣ, SmartRangeⅧ

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Nanjing RainGene Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000023111
UDI-DI: 06975178390038
Basic UDI-DI: 697517839AutoNAADAQ2
Reference: 030101CB
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 18:19

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920225

HBNP-ME32A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920225
Basic UDI-DI: 697515792HBNPME32AW5
Reference: HBNP-ME32A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920218

HB-IEX96S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920218
Basic UDI-DI: 697515792HBIEX96SBY
Reference: HB-IEX96S
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920164

HB-IEX96A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920164
Basic UDI-DI: 697515792HBIEX96AAU
Reference: HB-IEX96A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920133

HBNP-9601A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920133
Basic UDI-DI: 697515792HBNP9601AKY
Reference: HBNP-9601A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920102

HBNP-4803A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920102
Basic UDI-DI: 697515792HBNP4803AJV
Reference: HBNP-4803A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920089

HBNP-4801A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920089
Basic UDI-DI: 697515792HBNP4801AJP
Reference: HBNP-4801A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920065

HBHM-9000A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920065
Basic UDI-DI: 697515792HBHM9000AE6
Reference: HBHM-9000A
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920058

HBHM-3001S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920058
Basic UDI-DI: 697515792HBHM3001SDB
Reference: HBHM-3001S
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920034

HB-2012A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920034
Basic UDI-DI: 697515792HB2012ADL
Reference: HB-2012A
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920027

HHM-3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920027
Basic UDI-DI: 697515792HHM3PP
Reference: HHM-3
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

06975157920010

HBQW-3200A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hybribio Medtech Device Co.,Ltd
Manufacturer SRN: CN-MF-000023113
UDI-DI: 06975157920010
Basic UDI-DI: 697515792HBQW3200AMD
Reference: HBQW-3200A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction and Real-Time PCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GuangDong Brightbiomed Co., Ltd.
Manufacturer SRN: CN-MF-000046979
UDI-DI: 06975121510162
Basic UDI-DI: 697512151016GE
Reference: AutoPlex-Min
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 18:13

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction and Real-Time PCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GuangDong Brightbiomed Co., Ltd.
Manufacturer SRN: CN-MF-000046979
UDI-DI: 06975121510155
Basic UDI-DI: 697512151015GC
Reference: AutoPlex-12
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 18:13

Manufacturer products Authorised representative products Authorised representative actors View details

06975102680013

BJB Rapid Gene Detection System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Bojia Biomedical Technology Co., Ltd
Manufacturer SRN: CN-MF-000023653
UDI-DI: 06975102680013
Basic UDI-DI: 697510268A001B2
Reference: A-1-1
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time Fluorescence Quantitative PCR lnstrument

OPqPCR1600

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Wuxi Opulen Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023008
UDI-DI: 06975061571612
Basic UDI-DI: 697506157OPqPCR1600BL
Reference: N/A
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Real time fluorescence quantitative PCR Device

OP-qPCR1600C

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wuxi Opulen Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023008
UDI-DI: 06975061571605
Basic UDI-DI: 697506157OPqPCR1600C65
Reference: 1722023
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Full-Automatic Nucleic Acid Extraction and Purification Instrument

MN-9600B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Q-Array Co.,Ltd.
Manufacturer SRN: CN-MF-000044646
UDI-DI: 06975050590204
Basic UDI-DI: 697505059020JG
Reference: MN-9600B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 02.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time Quantitative Thermal Cycler

MA-688，MA-1610Q，MA-1620Q，MA-1630Q，MA-1640Q

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Q-Array Co.,Ltd.
Manufacturer SRN: CN-MF-000044646
UDI-DI: 06975050590006
Basic UDI-DI: 697505059000JA
Reference: MA-688
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 02.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details