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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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02.08.2026 18:51

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973 device results listed.

Page 48 / 49

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sikun Life Science Co., Ltd.
Manufacturer SRN: CN-MF-000047921
UDI-DI: 06975608185104
Basic UDI-DI: 697560818model01F9
Reference: 5104
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 16.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sikun Life Science Co., Ltd.
Manufacturer SRN: CN-MF-000047921
UDI-DI: 06975608185111
Basic UDI-DI: 697560818model01F9
Reference: 5111
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 16.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

YJSeq 300 Dx Sequencing Kit

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IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai YJMED BioTechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055692
UDI-DI: 06977334213038
Basic UDI-DI: 697733421RB01KG
Reference: YJSeq 300 Dx Kit
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

YJSeq 300 Dx Sequencing Kit

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IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai YJMED BioTechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055692
UDI-DI: 06977334213045
Basic UDI-DI: 697733421RB01KG
Reference: FCM 300cycles
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

YJSeq 300 Dx Sequencing System

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IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai YJMED BioTechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055692
UDI-DI: 06977334213052
Basic UDI-DI: 697733421RB01KG
Reference: FCH-D SE075-D
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

YJSeq 300 Dx Sequencing System

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IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai YJMED BioTechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055692
UDI-DI: 06977334213069
Basic UDI-DI: 697733421RB01KG
Reference: FCH 150cycles
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

YJSeq 300 Dx Sequencing System

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IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai YJMED BioTechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055692
UDI-DI: 06977334213076
Basic UDI-DI: 697733421RB01KG
Reference: FCH 300cycles
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

YJSeq 300 Dx Sequencing Kit

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IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai YJMED BioTechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055692
UDI-DI: 06977334213106
Basic UDI-DI: 697733421RB01KG
Reference: FCP-D SE075-D
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

YJSeq 300 Dx Sequencing Kit

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IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai YJMED BioTechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055692
UDI-DI: 06977334213113
Basic UDI-DI: 697733421RB01KG
Reference: FCP 150cycles
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

YJSeq 300 Dx Sequencing Kit

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IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai YJMED BioTechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055692
UDI-DI: 06977334213120
Basic UDI-DI: 697733421RB01KG
Reference: FCP 300cycles
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Suzhou Acumen Biomedical Technology Co., LTD.
Manufacturer SRN: CN-MF-000038603
UDI-DI: 06978704661138
Basic UDI-DI: 6978704662200FM
Reference: 220003
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Kingsmead Service B.V.
Last updated: 16.06.2026 11:36

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Suzhou Acumen Biomedical Technology Co., LTD.
Manufacturer SRN: CN-MF-000038603
UDI-DI: 06978704661145
Basic UDI-DI: 6978704662200FM
Reference: 220003
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Kingsmead Service B.V.
Last updated: 16.06.2026 11:36

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Suzhou Acumen Biomedical Technology Co., LTD.
Manufacturer SRN: CN-MF-000038603
UDI-DI: 06978704661152
Basic UDI-DI: 6978704662200FM
Reference: 220004-2
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Kingsmead Service B.V.
Last updated: 16.06.2026 11:36

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Suzhou Acumen Biomedical Technology Co., LTD.
Manufacturer SRN: CN-MF-000038603
UDI-DI: 06978704661169
Basic UDI-DI: 6978704662200FM
Reference: 220004-4
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Kingsmead Service B.V.
Last updated: 16.06.2026 11:36

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Suzhou Acumen Biomedical Technology Co., LTD.
Manufacturer SRN: CN-MF-000038603
UDI-DI: 06978704661176
Basic UDI-DI: 6978704662200FM
Reference: 220004-32
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Kingsmead Service B.V.
Last updated: 16.06.2026 11:36

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Suzhou Acumen Biomedical Technology Co., LTD.
Manufacturer SRN: CN-MF-000038603
UDI-DI: 06978704661183
Basic UDI-DI: 6978704662200FM
Reference: 220015-1
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: -
Authorised representative: Kingsmead Service B.V.
Last updated: 16.06.2026 11:36

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06979502241478
Basic UDI-DI: 697950224PCR1116016E
Reference: PCR111601
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.06.2026 11:25

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007690
Basic UDI-DI: 081164701-GX-X5
Reference: GeneXpert IV (GX-IV)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Cepheid AB
Last updated: 16.06.2026 10:31

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007706
Basic UDI-DI: 081164701-GX-X5
Reference: GeneXpert XVI (GX-XVI)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Cepheid AB
Last updated: 16.06.2026 10:31

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007720
Basic UDI-DI: 081164701-INFINITY-ZH
Reference: GX-INFINITY 80
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Cepheid AB
Last updated: 16.06.2026 10:31

Manufacturer products Authorised representative products Authorised representative actors View details