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

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15 device results listed.

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hyborg Dx RED2

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730015
Basic UDI-DI: 912012773HDR-001XD
Reference: 09120127730015
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Austria
Authorised representative: -
Last updated: 22.09.2026 00:24

Manufacturer products View details

06975102280169

GCP-30/GE4/GD-220

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou GenDx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018830
UDI-DI: 06975102280169
Basic UDI-DI: 697510228GD0017D
Reference: GCP-30
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 02:45

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIAN

MC-1000

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

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: 06934244500122
Basic UDI-DI: 69342445IA001FH
Reference: P112-00096
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Randox Discovery

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216943
Basic UDI-DI: 50552732ADISCOV018FH
Reference: RDC10000
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

iScan™Dx

iScanDx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020682
Basic UDI-DI: 0081627002iScan89
Reference: 20081314
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

BioArray Array Imaging System TM (AIS) 400D

400D

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 10888234102229
Basic UDI-DI: 088823479020016PM
Reference: 790-20016
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 16.07.2026 07:44

Manufacturer products Authorised representative products Authorised representative actors View details

GeneChip™ Fluidics Station FS450Dx v.2

GeneChip™ System 3000Dx v.2 Instrument System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Affymetrix, Inc.
Manufacturer SRN: US-MF-000028847
UDI-DI: 00856826006029
Basic UDI-DI: 0856826006000334CC
Reference: 00-0335 (00-0334)
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

BioArray Array Imaging System TM (AIS) 400D

400D

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioArray Solutions Ltd
Manufacturer SRN: US-MF-000022068
UDI-DI: 00850081948001
Basic UDI-DI: 08500819481WAY
Reference: 790-20016
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 16.07.2026 06:31

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630037

ICX Imager 500

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630037
Basic UDI-DI: 697604363ICXD003Q8
Reference: 003
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR System

FZ-960

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Everbest Machinery lndustry Co., Ltd.
Manufacturer SRN: CN-MF-000008730
UDI-DI: 06951110996117
Basic UDI-DI: 69511109FZ-960DC
Reference: FZ-960
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR System

FZ-80

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Everbest Machinery lndustry Co., Ltd.
Manufacturer SRN: CN-MF-000008730
UDI-DI: 06951110980253
Basic UDI-DI: 69511109FZ-80GD
Reference: FZ-80
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR System

FZ-3840

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Everbest Machinery lndustry Co., Ltd.
Manufacturer SRN: CN-MF-000008730
UDI-DI: 06951110938414
Basic UDI-DI: 69511109FZ-38408L
Reference: FZ-3840
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR System

FZ-100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Everbest Machinery lndustry Co., Ltd.
Manufacturer SRN: CN-MF-000008730
UDI-DI: 06951110910274
Basic UDI-DI: 69511109FZ-100BJ
Reference: FZ-100
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details

GeneChip™ Scanner 3000Dx v.2 with AutoLoaderDx v2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Affymetrix, Inc.
Manufacturer SRN: US-MF-000028847
UDI-DI: 00856826006036
Basic UDI-DI: 0856826006000334CC
Reference: 00-0336 (00-0334)
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 21.06.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

GCDC Dx Installer v1.0

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Affymetrix, Inc.
Manufacturer SRN: US-MF-000028847
UDI-DI: 00856826006203
Basic UDI-DI: 0856826006000334CC
Reference: 611403 (00-0334)
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 21.06.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details