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18.09.2026 23:40

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108 device results listed.

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GINA Lyse 200

GINA 500

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730664
Basic UDI-DI: 912012773GINA7H
Reference: 09120127730664
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: -
Last updated: 12.08.2026 23:34

Manufacturer products View details

MagCore® Giga Automated Nucleic Acid Extractor

MagCore® System

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingReagent

Manufacturer: RBCBioscience Corp.
Manufacturer SRN: TW-MF-000026757
UDI-DI: 04719890670076
Basic UDI-DI: 471989067M0000A9
Reference: MCA0802
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 05.08.2026 18:59

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360121

BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360121
Basic UDI-DI: 697551436BFEX001MK
Reference: BFEX-96E
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 05.08.2026 18:48

Manufacturer products Authorised representative products Authorised representative actors View details

MagCore® EDA Automated Nucleic Acid Extractor and Assay Setup

MagCore® System

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingReagent

Manufacturer: RBCBioscience Corp.
Manufacturer SRN: TW-MF-000026757
UDI-DI: 04719890670069
Basic UDI-DI: 471989067M0000A9
Reference: MDA4802
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 05.08.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

MagCore® Plus II Automated Nucleic Acid Extractor

MagCore® System

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingReagent

Manufacturer: RBCBioscience Corp.
Manufacturer SRN: TW-MF-000026757
UDI-DI: 04719890670052
Basic UDI-DI: 471989067M0000A9
Reference: MCA1605
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 05.08.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360114

BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360114
Basic UDI-DI: 697551436BFEX001MK
Reference: BFEX-96
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 05.08.2026 16:29

Manufacturer products Authorised representative products Authorised representative actors View details

MagCore® HF48 Automated Nucleic Acid Extractor

MagCore® System

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingReagent

Manufacturer: RBCBioscience Corp.
Manufacturer SRN: TW-MF-000026757
UDI-DI: 04719890670045
Basic UDI-DI: 471989067M0000A9
Reference: MCA4801
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 05.08.2026 16:02

Manufacturer products Authorised representative products Authorised representative actors View details

EXTRALAB

EXTRAlab

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: ADALTIS SRL
Manufacturer SRN: IT-MF-000028990
UDI-DI: ++M521XLB018J
Basic UDI-DI: B-++M521XLB018J
Reference: XLB01
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Romania
Authorised representative: -
Last updated: 04.08.2026 22:53

Manufacturer products View details

06975514360107

BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360107
Basic UDI-DI: 697551436BFEX001MK
Reference: BFEX-32
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

06937044500729

ES400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Ningbo HEALTH Gene Technologies Co., LTD.
Manufacturer SRN: CN-MF-000002278
UDI-DI: 06937044500729
Basic UDI-DI: 69370445egensA00000001YQ
Reference: A00000001
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

MagCore® HF16 Plus Automated Nucleic Acid Extractor

MagCore® System

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingReagent

Manufacturer: RBCBioscience Corp.
Manufacturer SRN: TW-MF-000026757
UDI-DI: 04719890670038
Basic UDI-DI: 471989067M0000A9
Reference: MCA1603
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

LINA

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730152
Basic UDI-DI: 912012773LINA8L
Reference: 09120127730152
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:42

Manufacturer products View details

GINA 500 + DNA purification

GINA 500

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730145
Basic UDI-DI: 912012773GINA7H
Reference: 09120127730145
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:42

Manufacturer products View details

GT NUCLEIC ACID PREP KIT

GT-PREP-1

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Genomictree, Inc.
Manufacturer SRN: KR-MF-000037890
UDI-DI: 18800076500461
Basic UDI-DI: 88000765PREP1PX
Reference: GT-PREP-1
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: KTR Europe GmbH
Last updated: 01.08.2026 00:04

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360091

BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360091
Basic UDI-DI: 697551436BFEX001MK
Reference: BFEX-16
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details

AutoMated Nucleic Acid Extraction System

GeneX E6, GeneX E6s

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605622
Basic UDI-DI: 69268026GeneXE600000001P2
Reference: GeneX E6
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

MagnisDx NGS Prep System

K1007A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700574036850
Basic UDI-DI: 570057R0802P3011A040500SJ
Reference: K1007A
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

Benchbot® 4800

4800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830750
Basic UDI-DI: 506053683BBOT01ZU
Reference: BBOT4800
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

magLEAD 4gC

magLEAD

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869111404
Basic UDI-DI: 4987869magLEAD4gCFK
Reference: A1140
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

magLEAD 12gC LiNK(Abalat)

magLEAD

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869111329
Basic UDI-DI: 4987869magLEAD12gCLiNKKM
Reference: A1132
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details