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32 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

Waste Bottle

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730046
Basic UDI-DI: 912012773HDR-004XK
Reference: 09120127730046
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:42

Manufacturer products View details

System Liquid

PE-Buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730022
Basic UDI-DI: 912012773HDR-005XM
Reference: 09120127730022
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:42

Manufacturer products 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

SureScan Dx Microarray Scanner

G5761A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700571108703
Basic UDI-DI: 570057R0802P3011A040200S3
Reference: G5761A
EMDN: W02050299
EMDN description: MICRO-ARRAY INSTRUMENTS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:50

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

PE-Buffer

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730138
Basic UDI-DI: 912012773HDR-005XM
Reference: 09120127730138
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 26.07.2026 18:08

Manufacturer products 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

TypeStream™ Visual Software version 3.2

TSVPRG

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00814695024445
Basic UDI-DI: 081469502TSVKN
Reference: TSVPGR
EMDN: W02050292
EMDN description: MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

ViraChip Software

Software

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRVCNUPR1
Basic UDI-DI: ++EVIRSoftware98
Reference: V-VCNUPR
EMDN: W02050292
EMDN description: MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:24

Manufacturer products View details

Fagron TrichoTest

IVD Class CIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: Fagron Genomics
Manufacturer SRN: ES-MF-000001092
UDI-DI: 1352022FGMS-TRI132
Basic UDI-DI: 8437024682FGMS-TrichoVJ
Reference: FGMS-Tricho
EMDN: W02050292
EMDN description: MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:18

Manufacturer products View details

13 52022 FGMS-TELO 1 16

Fagron TeloTest

IVD Class CIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: Fagron Genomics
Manufacturer SRN: ES-MF-000001092
UDI-DI: 13 52022 FGMS-TELO 1 16
Basic UDI-DI: 8437024682FGMS-TeloT3
Reference: FGMS-Telo
EMDN: W02050292
EMDN description: MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 15:18

Manufacturer products 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

06975491760150

SET-48、SET-96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Sciarray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000038307
UDI-DI: 06975491760150
Basic UDI-DI: 697549176ANAEAPIYC
Reference: SET-48
EMDN: W02050299
EMDN description: MICRO-ARRAY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

MAST ISOPLEX® CRE-ART

DNA/LYO5

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Mast Group Limited
Manufacturer SRN: GB-MF-000025209
UDI-DI: 15056152709485
Basic UDI-DI: 50561527LYO5NQ
Reference: DNA/LYO5
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Mast Diagnostica GmbH
Last updated: 02.07.2026 01:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAST ISOPLEX® E. coli O157

DNA/LYO4

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Mast Group Limited
Manufacturer SRN: GB-MF-000025209
UDI-DI: 15056152705333
Basic UDI-DI: 50561527LYO4NN
Reference: DNA/LYO4
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Mast Diagnostica GmbH
Last updated: 02.07.2026 01:54

Manufacturer products Authorised representative products Authorised representative actors View details