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Automatic Nucleic Acid Extraction System

N 32，N 96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168350775
Basic UDI-DI: 6972168353003A4
Reference: EGN9101006
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

06971980730178

akbbnf01 for windows

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou New Horizon Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027517
UDI-DI: 06971980730178
Basic UDI-DI: 697198037017MR
Reference: /
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

Bioda

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsMicrobial substancesSelf testingSingle useSterile

Manufacturer: Bioda Diagnostics (Wuhan) Co.,Ltd
Manufacturer SRN: CN-MF-000018803
UDI-DI: 06971223290070
Basic UDI-DI: 69712232900525L
Reference: 2 people/box
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Eonis EASI

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147402670
Basic UDI-DI: 6438147EonisEASI_88
Reference: 2044-3010
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Eonis Q96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147387700
Basic UDI-DI: 6438147EonisQ_4J
Reference: 2044-0010
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

chemagic Prime Jr-D

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147376209
Basic UDI-DI: 6438147chemagic_PrJr3L
Reference: 2029-0010
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Vanadis View

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147369324
Basic UDI-DI: 6438147Vanadis_ViewVE
Reference: 2028-0020
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Vanadis Core

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147369317
Basic UDI-DI: 6438147Vanadis_CoreSA
Reference: 2027-0020
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Vanadis Extract

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147369300
Basic UDI-DI: 6438147Vanadis_Extract9Y
Reference: 2026-0020
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

chemagic 360-D

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147356706
Basic UDI-DI: 6438147chemagic_360-DZ2
Reference: 2024-0010
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

chemagic Prepito-D

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147332205
Basic UDI-DI: 6438147chemagic_Prep5J
Reference: 2022-0020
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Novodiag Instrument

Novodiag System

IVD Class AIVDR 2017/746No longer on the marketInstrumentProfessional testing

Manufacturer: Mobidiag Ltd.
Manufacturer SRN: FI-MF-000001215
UDI-DI: 06430041760030
Basic UDI-DI: 643004176B0039MJ
Reference: NVD-INST-B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 08:54

Manufacturer products View details

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