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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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Auto 12 Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860099
Basic UDI-DI: 697414986Auto12DxPQ
Reference: H351000
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 15:29

Manufacturer products Authorised representative products Authorised representative actors View details

qMate mini Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860068
Basic UDI-DI: 697414986027NA
Reference: H691101
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 15:29

Manufacturer products Authorised representative products Authorised representative actors View details

Kingwell 96 Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860051
Basic UDI-DI: 697414986Kingwell96LE
Reference: H611101
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 15:29

Manufacturer products Authorised representative products Authorised representative actors View details

ONEblot Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860044
Basic UDI-DI: 697414986ONEblotDxC6
Reference: H511001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 15:28

Manufacturer products Authorised representative products Authorised representative actors View details

XW Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860020
Basic UDI-DI: 697414986XW3XH
Reference: H631104
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 15:28

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

AutoGene 9600 Automatic PCR Analysis System

FQD-A9600(EA4), FQD-A9600(EA5), FQD-A9600(EA6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221342
Basic UDI-DI: 697384322FQD010GR
Reference: FQD-A9600(EA4)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene 9600 Pro Fluorescenct Quantitative Detection System

FQD-96A(ED2), FQD-96A(ED4), FQD-96A(ED5), FQD-96A(ED6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221304
Basic UDI-DI: 697384322FQD009H8
Reference: FQD-96A(ED2)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

careSTART™ Q1 Amplifier

TQA-E00182

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221298
Basic UDI-DI: 697384322FQD008H6
Reference: TQA-E00182
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

GenePure Pro 16H Nucleic Acid Purification System

NPA-16H

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221274
Basic UDI-DI: 697384322NPA001JY
Reference: NPA-16H
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

VitroCycler Fluorescent Quantitative Detection System

VIT-VitroCycler

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221267
Basic UDI-DI: 697384322FQD007H4
Reference: VIT-VitroCycler
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

GenePure Pro 9600 Nucleic Acid Purification System

NPAm-9600

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221205
Basic UDI-DI: 697384322NPA005K8
Reference: NPAm-9600
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

CentriDx Automated Nucleic Acid Analyzer

CentriDx 200(EA4) , CentriDx 200(EA5) , CentriDx 200(EA6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221175
Basic UDI-DI: 697384322FQD012GV
Reference: CentriDx 200(EA4)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

Bioquant-96m Fluorescent Quantitative Detection System

Bioquant-96m

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221168
Basic UDI-DI: 697384322FQD011GT
Reference: Bioquant-96m
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene 9600 Plus Fluorescent Quantitative Detection System

FQD-96A(EA2), FQD-96A(EA4), FQD-96A(EA5), FQD-96A(EA6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220765
Basic UDI-DI: 697384322FQD004GW
Reference: FQD-96A(EA2)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

GeneExplorer Thermal Cycler

GE-96G, GE-96S, GE-48DG, GE-384G, GE-4I, GE-48D, GE-48DS,GE-DX

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220734
Basic UDI-DI: 697384322TC001H3
Reference: GE-96G
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Nucleic Acid Purification and Real Time PCR System

FQD-A1600(EA4), FQD-A1600(EA5), FQD-A1600(EA6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220680
Basic UDI-DI: 697384322FQD006H2
Reference: FQD-A1600(EA4)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Nucleic Acid Purification System

NPAs-9600,NPAs-9620

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220673
Basic UDI-DI: 697384322NPA004K6
Reference: NPAs-9600
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

GenePure Pro Nucleic Acid Purification System

NPA-32P, NPA-32E

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220659
Basic UDI-DI: 697384322NPA002K2
Reference: NPA-32P
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details