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97 device results listed.

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Revogene® Mock Pie

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Meridian Bioscience Inc.
Manufacturer SRN: US-MF-000044096
UDI-DI: 00840733102332
Basic UDI-DI: 008407331REVOGENECLA003TK
Reference: 610208
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: Meridian Bioscience Europe S.r.l.
Last updated: 15.07.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

GT NUCLEIC ACID PREP KIT

IVD Class ANot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Genomictree, Inc.
Manufacturer SRN: KR-MF-000037890
UDI-DI: 18800076500508
Basic UDI-DI: 88000765PREP1PX
Reference: GT-PREP-3
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: KTR Europe GmbH
Last updated: 11.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

PowerEXP™ 48LH

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056348000
Basic UDI-DI: 88000563KE48005Y
Reference: KE4800
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

RADIONE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204301871
Basic UDI-DI: 880002043POCF8
Reference: KM009
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

Anatolia Geneworks

Unio M32 Extraction System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08684198020082
Basic UDI-DI: 868001894EXIAUM32AH
Reference: AUM32
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:18

Manufacturer products View details

Anatolia Geneworks

Unio B48 Extraction System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08684198020075
Basic UDI-DI: 868001894EXIUNI048019K
Reference: AUB48
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:18

Manufacturer products View details

Anatolia Geneworks

Unio 96 Extraction and PCR Setup Robot

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08684198020068
Basic UDI-DI: 868001894EXIUNI09601AC
Reference: AUH96
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:18

Manufacturer products View details

Anatolia Geneworks

Unio B24 Extraction System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08680018946600
Basic UDI-DI: 868001894EXIUNI024018H
Reference: AUB24
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 17:11

Manufacturer products View details

Anatolia Geneworks

Magnesia 2448 Nucleic Acid Extraction & PCR Setup Robot

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08680018940585
Basic UDI-DI: 868001894EXIMGS0480156
Reference: MAG48
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:10

Manufacturer products View details

Anatolia Geneworks

Magnesia 16 Nucleic Acid Extraction Instrument

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08680018940110
Basic UDI-DI: 868001894EXIDE-010D9
Reference: DE-010
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:10

Manufacturer products View details

Anatolia Geneworks

Unio A24S Extraction & PCR Setup System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08684198020976
Basic UDI-DI: 868001894EXIAUA24SQE
Reference: AUA24S
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:08

Manufacturer products View details

Nucleic Acid Purification System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bio-gener Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027988
UDI-DI: 16980047303009
Basic UDI-DI: 698004730300FQ
Reference: BGNA-32P
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 03.07.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

06979502241492

MagiCube 48

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06979502241492
Basic UDI-DI: 697950224MC1048CD
Reference: MC1048
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

CHK Biotech

CHK-3200 CHK-16S CHK-800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Chuangkun Biotech Inc.
Manufacturer SRN: CN-MF-000032705
UDI-DI: 06976014644018
Basic UDI-DI: 697601464ANAE01DA
Reference: N/A
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Greece
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Purification System

NAE24 PIus

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: SINGLERA GENOMICS (JIANGSU) LTD.
Manufacturer SRN: CN-MF-000033428
UDI-DI: 06975970650026
Basic UDI-DI: 697597065INST04ZN
Reference: INST040024CE
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Purification System

CaptureRevo NAE24

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: SINGLERA GENOMICS (JIANGSU) LTD.
Manufacturer SRN: CN-MF-000033428
UDI-DI: 06975970650019
Basic UDI-DI: 697597065021QE
Reference: INST020024CE
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Nucleic Acid Detection Reaction Construction System

AP10

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360020
Basic UDI-DI: 697557836020020001YH
Reference: 1000042
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

06975330320026

AUTO-MAGec 32

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou MiYin Biotechnology Co.,Ltd
Manufacturer SRN: CN-MF-000041649
UDI-DI: 06975330320026
Basic UDI-DI: 697533032MYNAPSSY
Reference: AUTO-MAGec 32
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details