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GeneXpert®

GeneXpert® Infinity Systems

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

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007713
Basic UDI-DI: 081164701-INFINITY-ZH
Reference: GX-INFINITY 48S
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

GeneXpert

GeneXpert® Dx Systems

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

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940007683
Basic UDI-DI: 081164701-GX-X5
Reference: GeneXpert II (GX-II)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® Check

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940001865
Basic UDI-DI: 081164701-XPERTCHECK-3B
Reference: XPERTCHECK-CE-5
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

07350148190006

Qlucore Diagnostics Platform

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissues

Manufacturer: Qlucore AB(publ)
Manufacturer SRN: SE-MF-000030781
UDI-DI: 07350148190006
Basic UDI-DI: 07350148191KA
Reference: QD Platform,
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 16.07.2026 03:02

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FOX

BD FOX™ PCR Extraction Tubes

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904419920
Basic UDI-DI: 038290ZMTAUZEXRG
Reference: 441992
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

FOX

BD FOX™ Extraction Tubes

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904411290
Basic UDI-DI: 038290OJLDQOTODD
Reference: 441129
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Not Applicable

BD PCR Cartridge

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904375196
Basic UDI-DI: 038290YMCUPXTNQ8
Reference: 437519
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

COR

BD COR™ GX INSTRUMENT

IVD Class AIVDR 2017/746On the marketAnimal tissuesInstrumentProfessional testing

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904439903
Basic UDI-DI: 038290TFCJEOYLAA
Reference: 443990
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

MAX

BD MAX™ System

IVD Class AIVDR 2017/746On the marketAnimal tissuesInstrumentProfessional testing

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904419165
Basic UDI-DI: 038290UZTXHTZA26
Reference: 441916
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

VIPER

BD Specimen Tubes and Caps for use on the BD Viper™ System

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 30382904413607
Basic UDI-DI: 038290IEHRMMUH8T
Reference: 441360
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:39

Manufacturer products Authorised representative products Authorised representative actors View details

Not Applicable

BD Pre-warm Heater

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904431594
Basic UDI-DI: 038290MLZISLOML2
Reference: 443159
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

VIPER

BD Viper™ LT System PCR Accessory Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904429676
Basic UDI-DI: 038290KNHKHNPYC2
Reference: 442967
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

VIPER

BD Viper™ LT System PCR Tube / Tray Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904429577
Basic UDI-DI: 038290GHEXZRWPED
Reference: 442957
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Not Applicable

BD PREWARM HEATER

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904429508
Basic UDI-DI: 038290OAEMHDBH32
Reference: 442950
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

VIPER

BD Viper LT system software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904429485
Basic UDI-DI: 038290HGAGGXEJZL
Reference: 442948
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

PGDx elio tissue complete

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testingReagent

Manufacturer: Personal Genome Diagnostics, Inc.
Manufacturer SRN: US-MF-000026862
UDI-DI: 00192721001470
Basic UDI-DI: 0192721U0200100NL
Reference: B01102200
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 15.07.2026 23:03

Manufacturer products Authorised representative products Authorised representative actors View details

CBC Wash Septa Clip Dx

CBC Wash Septa Clip, a part of Genetic Analyzer Reagents and Consumables

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302019736
Basic UDI-DI: 0190302A66359TG
Reference: A66359
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Applied Biosystems™ SeqStudio™ 8 Flex Dx Genetic Analyzer

Applied Biosystems™ SeqStudio™ Flex Dx Series Genetic Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302018838
Basic UDI-DI: 0190302A50534RM
Reference: A50534
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Target Test User Guides and Assay Definition File

A54452

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302018333
Basic UDI-DI: 0190302A54452SE
Reference: A54452 (A65538)
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Diomni™ Software V3.1.0

Diomni™ Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302018135
Basic UDI-DI: 0190302TCF00005384V
Reference: A54762 (A56307)
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details