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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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500 device results listed.

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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

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

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

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

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QuantStudio™ 7 Pro Dx Real‑Time PCR Instrument

QuantStudio™ 7 Pro Dx Real-Time PCR Instrument and Accessories

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302016148
Basic UDI-DI: 0190302TCF00005354P
Reference: A50745
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

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QuantStudio™ 5 Dx Real‑Time PCR Instrument (96-Well 0.2ml Block)

QuantStudio™ 5 Dx Real-Time PCR System and Accessories

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302015592
Basic UDI-DI: 0190302A47326SJ
Reference: A47324 (A47326, A47327)
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

3500 Dx Genetic Analyzer

Applied Biosystems™ 3500 Dx/3500xL Dx Genetic Analyzers

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302005937
Basic UDI-DI: 0190302TCF00005084L
Reference: 4405182 (A27772)
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Ion PGM™ Dx Sequencer

Ion Personal Genome Machine (PGM™) Dx Instrument System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000833
Basic UDI-DI: 0190302A25511RB
Reference: 4485656
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 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Revogene®

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Meridian Bioscience Inc.
Manufacturer SRN: US-MF-000044096
UDI-DI: 00840733102318
Basic UDI-DI: 008407331REVOGENECLA001TF
Reference: 610210
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Meridian Bioscience Europe S.r.l.
Last updated: 15.07.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Alethia

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Meridian Bioscience Inc.
Manufacturer SRN: US-MF-000044096
UDI-DI: 00840733101663
Basic UDI-DI: 008407331ALETHIACLA001QV
Reference: 610189
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Meridian Bioscience Europe S.r.l.
Last updated: 15.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

SAMBA III Tablet Module

I190007TM

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

Manufacturer: Diagnostics for the Real World (Europe) Ltd.
Manufacturer SRN: UK-MF-000047660
UDI-DI: G763I190007TM0
Basic UDI-DI: ++G763I190007TM3C
Reference: I190007TM
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

SAMBA III Assay Module

I190007AM

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

Manufacturer: Diagnostics for the Real World (Europe) Ltd.
Manufacturer SRN: UK-MF-000047660
UDI-DI: ++G763I190007AM0
Basic UDI-DI: ++G763I190007AMZG
Reference: I190007AM
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Ireland
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 15.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 4M1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014360505
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME4M1-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 4М3

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362370
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME4M3-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 4М6

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362387
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME4M6-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 5М3

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362417
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME5M3-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 5М6

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362424
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME5M6-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 4Х1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362363
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME4Х1-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR instrument DTprime 5Х1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362400
Basic UDI-DI: 466001436DA02ZN
Reference: O-DTPRIME5Х1-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 14.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details