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977 device results listed.

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GeneMind

RPseq_analysis

IVD generalIVDDOn the marketProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584091
Basic UDI-DI: B-06974968584091
Reference: L000124
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

GeneMind

MTBseq_analysis

IVD generalIVDDOn the marketProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584077
Basic UDI-DI: B-06974968584077
Reference: L000121
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 21:08

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Whole Genome Copy Number Variation Analysis Software

CNV-SEQ_analysis

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583278
Basic UDI-DI: B-06974968583278
Reference: I000005
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 06.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

GeneMind

PGTA_analysis

IVD generalIVDDOn the marketProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583261
Basic UDI-DI: B-06974968583261
Reference: I000004
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 06.07.2026 21:08

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Fetal Chromosome Aneuploidy Analysis Software

NIPT_analysis

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583254
Basic UDI-DI: B-06974968583254
Reference: I000003
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 06.07.2026 21:07

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Automatic Nucleic Acid Extractor

NEX-96

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891339
Basic UDI-DI: B-06974674891339
Reference: 18-06-0004
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

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Automatic Nucleic Acid Extractor

NEX-32

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891322
Basic UDI-DI: B-06974674891322
Reference: 18-06-0003
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

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Genexpath

RT-MIS

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Genexpath
Manufacturer SRN: FR-MF-000029325
UDI-DI: 03770026953082
Basic UDI-DI: B-03770026953082
Reference: RT-MIS
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:33

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04899959024528

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: QUANTIDX HONG KONG LIMITED
Manufacturer SRN: HK-MF-000023647
UDI-DI: 04899959024528
Basic UDI-DI: 489995902451SL
Reference: SimpiDx Q16S
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 05.07.2026 19:18

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Mic IVD Automation

Mic IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Bio-Molecular Systems Pty Ltd
Manufacturer SRN: AU-MF-000025328
UDI-DI: 09357795000038
Basic UDI-DI: 93577950MicIVDG7
Reference: MIC-IVD AUTOMATION
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Türkiye
Authorised representative: mdi Europa GmbH
Last updated: 04.07.2026 00:08

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MT-Prep 24 System

Nucleic acid sample preparation instrument IVD, automated

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003578
Basic UDI-DI: 93430440W02050106U2
Reference: 93100
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Malta
Authorised representative: R-Biopharm AG
Last updated: 04.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

RapiCycler 96 Real Time PCR System-(6-Channel)

G2MRAPI4002

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200094
Basic UDI-DI: 890617820G2MRAPI4002CX
Reference: G2MRAPI4002
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

RapiCycler 96 Real Time PCR System (4-Channel)

G2MRAPI4001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: 08906178200087
Basic UDI-DI: 890617820G2MRAPI4001CV
Reference: G2MRAPI4001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

AutoMax

AutoMax Alkaline wash solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Avecon Healthcare Pvt. Ltd.
Manufacturer SRN: IN-MF-000040691
UDI-DI: 89061707101572
Basic UDI-DI: 890617071SPDETLB
Reference: SPDET-160
EMDN: W02050109
EMDN description: CELL WASHERS
First on market country: Cyprus
Authorised representative: Amstermed B.V.
Last updated: 03.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

MAXCLEAN

Maxclean wash solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Avecon Healthcare Pvt. Ltd.
Manufacturer SRN: IN-MF-000040691
UDI-DI: 89061707101404
Basic UDI-DI: 890617071AVCWSGW
Reference: AVCWS - 200
EMDN: W02050109
EMDN description: CELL WASHERS
First on market country: Cyprus
Authorised representative: Amstermed B.V.
Last updated: 03.07.2026 21:50

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880988550085PM

AIamp Arcus96S, AIamp Arcus96L

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AIGENE Co., Ltd.
Manufacturer SRN: KR-MF-000041502
UDI-DI: 880988550085PM
Basic UDI-DI: 880988550085PM
Reference: Arcus96
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 03.07.2026 21:10

Manufacturer products Authorised representative products Authorised representative actors View details

08809886490002

nucleic acid extractor

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: HANWOOLTPC Co., Ltd.
Manufacturer SRN: KR-MF-000026674
UDI-DI: 08809886490002
Basic UDI-DI: 880988649HWTPC-NC15PLUSL4
Reference: HWTD-01-32
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: JaviTech e.K.
Last updated: 03.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

G_PCR Chip Case

CTG01-04

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940155
Basic UDI-DI: 880974094ACC01EB
Reference: CTG01-04
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Belgium
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

LOAA-M POWERBOX

LAM306-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940117
Basic UDI-DI: 880974094LAM306J3
Reference: LAM306-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

LOAA-M Module

LAM304-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: OPTOLANE Technologies Inc.
Manufacturer SRN: KR-MF-000026042
UDI-DI: 08809740940070
Basic UDI-DI: 880974094LAM304HX
Reference: LAM304-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details