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AutoMated Nucleic Acid Extraction System

IVD Class ANot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605639
Basic UDI-DI: 69268026GeneXE600000001P2
Reference: GeneX E6s
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

BasePurifier

BasePurifier™ 32 Nucleic Acid Extraction System 32 Oscillating Rods

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000533
Basic UDI-DI: 5713915BP001NK
Reference: 715
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BaseTyper

BaseTyper™ 96.4 Flexible Real-Time PCR System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000557
Basic UDI-DI: 5713915BT004PM
Reference: 759
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BaseTyper

BaseTyper™ 96.6 Flexible Real-Time PCR System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000540
Basic UDI-DI: 5713915BT003PK
Reference: 758
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BasePurifier

BasePurifier™ 96 Nucleic Acid Extraction System 96 Rotating Rods

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000526
Basic UDI-DI: 5713915BP002NM
Reference: 719
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BasePurifier

BasePurifier™ 48 Large Volume Nucleic Acid Extraction System 48 Rotating Rods

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000519
Basic UDI-DI: 5713915BP003NP
Reference: 718
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BaseTyper

BaseTyper™ 16.2 Portable Real-Time PCR System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000144
Basic UDI-DI: 5713915BT002PH
Reference: 712
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

BaseTyper

BaseTyper™ 48.4 Quiet HRM Real-Time PCR System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000014
Basic UDI-DI: 5713915BT001PF
Reference: 754
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

GridION Sequencing Device Dx1 RGL

GridION Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingReagent

Manufacturer: Oxford Nanopore Diagnostics Limited
Manufacturer SRN: UK-MF-000046755
UDI-DI: 05056793800001
Basic UDI-DI: 50567938OND-GRD-Dx1-RGLKR
Reference: OND-GRD-DX1-RGL
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 02.07.2026 02:01

Manufacturer products Authorised representative products Authorised representative actors View details

NeXgen 16HP

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zinexts Life Science Corp.
Manufacturer SRN: TW-MF-000026758
UDI-DI: 04719889680154
Basic UDI-DI: 471988968AA131F6
Reference: 131A1
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 00:31

Manufacturer products Authorised representative products Authorised representative actors View details

Chroma ATE

GenXplore q4800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CHROMA ATE INC.
Manufacturer SRN: TW-MF-000019529
UDI-DI: 04719889100102
Basic UDI-DI: 471988910GX2W
Reference: GenXplore q4800
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

04719880129751

SLA-E13200

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880129751
Basic UDI-DI: 471988012SLAE1320044
Reference: SLA-E13200
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880129485

Maelstrom 9600

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880129485
Basic UDI-DI: 471988012M96007R
Reference: Maelstrom 9600 (110V)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880129454

Maelstrom 9610

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880129454
Basic UDI-DI: 471988012M96107U
Reference: Maelstrom 9610 (220V)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880129171

Maelstrom 4810

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880129171
Basic UDI-DI: 471988012M481073
Reference: Maelstrom 4810 (110V)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880128884

Maelstrom 2410

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880128884
Basic UDI-DI: 471988012M24105Z
Reference: Maelstrom 2410 (220V)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880128822

Maelstrom 9610 LH

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880128822
Basic UDI-DI: 471988012M96LHBQ
Reference: Maelstrom 9610 LH
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Sweden
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

04719880128600

Maelstrom 8 Autostage

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentProfessional testing

Manufacturer: Taiwan Advanced Nanotech Inc.
Manufacturer SRN: TW-MF-000019040
UDI-DI: 04719880128600
Basic UDI-DI: 471988012S04LG
Reference: Maelstrom Switch 8
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: mdi Europa GmbH
Last updated: 02.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 808 Nucleic Acid Extraction System

IVD Class ANot specifiedOn the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702078
Basic UDI-DI: 695629970003P3
Reference: 501102
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 960 Nucleic Acid Extraction System

IVD Class ANot specifiedOn the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702085
Basic UDI-DI: 695629970003P3
Reference: 501103
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details