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Hybrid Capture System Rotary Shaker 1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 04053228028031
Basic UDI-DI: 4053228IHCSSHAKER0000013S
Reference: 6000-2240E
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Austria
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:23

Manufacturer products Authorised representative products Authorised representative actors View details

Rotor-Gene Q MDx 5Plex

Rotor-Gene Q MDx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228022077
Basic UDI-DI: 4053228IRGQ000000000001QQ
Reference: 9002020
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:22

Manufacturer products View details

Rapid Capture System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 04053228010821
Basic UDI-DI: 4053228IHPVRCS000000001K8
Reference: 6000-3101
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Austria
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

DML 3000

digene Microplate Luminometer 3000 (DML 3000)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 04053228010777
Basic UDI-DI: 4053228IHC2DML0000000017V
Reference: 5000-00031
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

QIAsymphony AS

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228010746
Basic UDI-DI: 4053228IQSAS00000000001SA
Reference: 9001301
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:22

Manufacturer products View details

QIAsymphony SP

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228010739
Basic UDI-DI: 4053228IQSSP00000000001DY
Reference: 9001297
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:22

Manufacturer products View details

04049095260674

RIDA®SEEK

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095260674
Basic UDI-DI: 4049095ZRIDASEEK0FN
Reference: ZRIDASEEK
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:53

Manufacturer products View details

04049095260223

RIDA®UNITY

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095260223
Basic UDI-DI: 4049095ZUNITY0000PA
Reference: ZUNITY
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:53

Manufacturer products View details

Analyzer GENERIC HBV VL 2.0 FCXT

Analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003945
Basic UDI-DI: 40490550300001109UE
Reference: 1901991
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

GTQ-Cycler 96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003860
Basic UDI-DI: 40490550300001083UM
Reference: 1876820
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

FluoroSoftware® XT-IVD

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003839
Basic UDI-DI: 40490550300001091UL
Reference: 1897070
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

FluoroSoftware® IVD

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003822
Basic UDI-DI: 40490550300001090UJ
Reference: 1897069
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

GenoXtract® fleXT Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003815
Basic UDI-DI: 40490550300001089UZ
Reference: 1896938
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

WorklistGenerator

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003808
Basic UDI-DI: 40490550300001088UX
Reference: 1896936
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

FluoroCycler® XT

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003396
Basic UDI-DI: 40490550300001072UG
Reference: 2017
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details

FluoroCycler® 12

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002993
Basic UDI-DI: 40490550300001070UC
Reference: 7027001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details

TwinCubator

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055002641
Basic UDI-DI: 40490550300001078UU
Reference: 7025009
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details

GT-Blot 48

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055000500
Basic UDI-DI: 40490550300001077US
Reference: 1003/1
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:47

Manufacturer products View details

03770028804030

Congenica Rare Disease

IVD Class CIVDR 2017/746On the marketDirect marking

Manufacturer: SEQONE
Manufacturer SRN: FR-MF-000028525
UDI-DI: 03770028804030
Basic UDI-DI: 3770028804CRD6G
Reference: CRD
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 16:09

Manufacturer products View details

03770028804023

Variant LifePipe

IVD Class CIVDR 2017/746On the marketDirect marking

Manufacturer: SEQONE
Manufacturer SRN: FR-MF-000028525
UDI-DI: 03770028804023
Basic UDI-DI: 3770028804VLP9M
Reference: VLP
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:09

Manufacturer products View details