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12 device results listed.

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digene HC2 DNA Collection Device

Class IMDR 2017/745On the marketSingle use

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 14053228010361
Basic UDI-DI: 4053228MDIGENE0010000016Q
Reference: 619234
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: QIAGEN GmbH
Last updated: 16.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

PAXgene

768165

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingSingle useSterile

Manufacturer: PreAnalytiX GmbH
Manufacturer SRN: CH-MF-000033445
UDI-DI: 04053727681652
Basic UDI-DI: 4053727FBROCKIYX7
Reference: 768165
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Belgium
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:24

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PAXgene

762165

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingSingle useSterile

Manufacturer: PreAnalytiX GmbH
Manufacturer SRN: CH-MF-000033445
UDI-DI: 04053727621658
Basic UDI-DI: 4053727OQXSHDWXHN
Reference: 762165
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Belgium
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:24

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PAXgene

761165

IVD Class AIVDR 2017/746On the marketProfessional testingSingle useSterile

Manufacturer: PreAnalytiX GmbH
Manufacturer SRN: CH-MF-000033445
UDI-DI: 04053727611659
Basic UDI-DI: 4053727LZCYGBEZC4
Reference: 761165
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Belgium
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:24

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PAXgene Blood RNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: PreAnalytiX GmbH
Manufacturer SRN: CH-MF-000033445
UDI-DI: 04053727000132
Basic UDI-DI: 4053727RPAXBOD000000001GF
Reference: 762174
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details

QIAsymphony PAXgene Blood ccfDNA Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: PreAnalytiX GmbH
Manufacturer SRN: CH-MF-000033445
UDI-DI: 04053727000057
Basic UDI-DI: 4053727RQSPAXBOD00000016M
Reference: 768566
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details

Hybrid Capture System Multi-Specimen Tube Vortexer 2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 04053228028048
Basic UDI-DI: 4053228IHCSVortexer0001KP
Reference: 6000-5022
EMDN: W02070401
EMDN description: LABORATORY SHAKERS
First on market country: Austria
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:23

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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

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Hybrid Capture System Microplate Heater 1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 04053228028024
Basic UDI-DI: 4053228IHCSHEATER000001SJ
Reference: 6000-1240U
EMDN: W02079012
EMDN description: LABORATORY HOTPLATES
First on market country: Austria
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:23

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Hybrid Capture System Automated Plate Washer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 04053228028017
Basic UDI-DI: 4053228IHCSWASHER000001FS
Reference: 6000-00175
EMDN: W02079099
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: QIAGEN GmbH
Last updated: 01.07.2026 19:23

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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