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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

Genedrive® System

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Genedrive Diagnostics Ltd.
Manufacturer SRN: GB-MF-000012810
UDI-DI: 05060654860172
Basic UDI-DI: 506065486GS-00X2F
Reference: GS-002 V4.0
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Greece
Authorised representative: Advena Limited
Last updated: 02.07.2026 02:30

Manufacturer products Authorised representative products Authorised representative actors View details

DNA Fragmentation Quantification Assay

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830231
Basic UDI-DI: 506053683FQA001Y4
Reference: FQA-RT40
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Poland
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 02.07.2026 02:23

Manufacturer products Authorised representative products Authorised representative actors 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

MAST ISOPLEX® CRE-ART

DNA/LYO5

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Mast Group Limited
Manufacturer SRN: GB-MF-000025209
UDI-DI: 15056152709485
Basic UDI-DI: 50561527LYO5NQ
Reference: DNA/LYO5
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Mast Diagnostica GmbH
Last updated: 02.07.2026 01:54

Manufacturer products Authorised representative products Authorised representative actors View details