Public EUDAMED Search

EUDAMED Device Search

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

TR EN

Last updated

04.08.2026 10:01

Sync status

Successful

Device

3010742

Actor

47533

Certificate

3181

Filters

Show filters

Active filter:EMDN:W020501

977 device results listed.

Page 25 / 49

CSV XML

Uni-medica

NFAST 96, NFAST 32A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Uni-medica Technology Co., Ltd.
Manufacturer SRN: CN-MF-000022946
UDI-DI: 06974561520113
Basic UDI-DI: 697456152NFAST32ABE
Reference: 15.09.002.02
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 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565035

AU1001,AU1001S,AU1001-96

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565035
Basic UDI-DI: 697454156003KX
Reference: AU1001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Croatia
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974454727308

CWX901/CWX902/CWX903

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu CoWin Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008981
UDI-DI: 06974454727308
Basic UDI-DI: 697445472V21006X901-90344
Reference: CWX901
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction and Real-Time PCR System

ABT-24

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018025
Basic UDI-DI: 697432301YQ002FF
Reference: MP112401
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 15:54

Manufacturer products Authorised representative products Authorised representative actors View details

Genetic Sequencer DNBSEQ-G50

DNBSEQ-G50, DNBSEQ-G400, DNBSEQ-T7, DNBSEQ-G99, DNBSEQ-G99A, HELICON® G400, HELICON® G50

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318130008
Basic UDI-DI: 697431813SEQSY
Reference: 900-000352-00
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:51

Manufacturer products Authorised representative products Authorised representative actors View details

06974149860143

Pangaea Super 8 Pro Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860143
Basic UDI-DI: 69741498614YV
Reference: H622202
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

06974149860112

Pangaea 3fast/4fast/5fast/6fast

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860112
Basic UDI-DI: 69741498611YP
Reference: H621103，H621104，H621105，H621106
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

06974149860099

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

06974149860068

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

06974149860051

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

06974149860044

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

06974149860020

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