Public EUDAMED Search

EUDAMED Device Search

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

TR EN

Last updated

14.10.2026 18:46

Sync status

Successful

Device

4139742

Actor

48059

Certificate

3479

Filters

Show filters

Active filter:Authorised representative SRN:DE-AR-000006262

364 device results listed.

Page 1 / 19

Special Stains Nuclear Fast Red CS

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Ventana Medical Systems, Inc
Manufacturer SRN: US-MF-000016993
UDI-DI: 07613336222027
Basic UDI-DI: 761333603568BM
Reference: 09855955001
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 13.10.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Special Stains Eosin CS

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Ventana Medical Systems, Inc
Manufacturer SRN: US-MF-000016993
UDI-DI: 07613336175118
Basic UDI-DI: 761333603567BK
Reference: 09137971001
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 13.10.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Jones Stain Core Kit

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Ventana Medical Systems, Inc
Manufacturer SRN: US-MF-000016993
UDI-DI: 07613336175057
Basic UDI-DI: 761333603566BH
Reference: 09139770001
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 13.10.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

AcfS Software

Ariosa® cell-free DNA System (AcfS) Software

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Roche Molecular Systems, Inc.
Manufacturer SRN: US-MF-000018066
UDI-DI: 07613336155905
Basic UDI-DI: 761333603580BB
Reference: 07831773001
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 13.10.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Harmony IVD Kit

IVD Class CNot specifiedOn the market

Manufacturer: Roche Molecular Systems, Inc.
Manufacturer SRN: US-MF-000018066
UDI-DI: 07613336156049
Basic UDI-DI: 761333603581BD
Reference: 08011281001
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 09.10.2026 08:19

Manufacturer products Authorised representative products Authorised representative actors View details

ePlex Instrument

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GenMark Diagnostics
Manufacturer SRN: US-MF-000010772
UDI-DI: 00857167005009
Basic UDI-DI: 0857167005RM0030017M
Reference: RM003001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Roche Diagnostics GmbH
Last updated: 01.10.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

cobas® eplex system

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GenMark Diagnostics
Manufacturer SRN: US-MF-000010772
UDI-DI: 00857167005382
Basic UDI-DI: 085716700510107545001KP
Reference: 10107545001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Roche Diagnostics GmbH
Last updated: 01.10.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

cobas® eplex respiratory pathogen panel 3 (RP3)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: GenMark Diagnostics
Manufacturer SRN: US-MF-000010772
UDI-DI: 00857167005399
Basic UDI-DI: 085716700510246944001PN
Reference: 10246944001
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Roche Diagnostics GmbH
Last updated: 01.10.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

cobas e 801 analytical unit

cobas 8000 modular analyzer series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07813338158458
Basic UDI-DI: 761333601561AR
Reference: 08454345001
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:04

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series Language Pack - English Version 4.11.en

cobas 8100 automated workflow series

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243343
Basic UDI-DI: 761333603408AW
Reference: 10716142001
EMDN: W02069082
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series System Software Version 04-11

cobas 8100 automated workflow series

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243336
Basic UDI-DI: 761333603407AU
Reference: 10716134001
EMDN: W02069082
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

Phadia-250 Connector to cobas 8100 (PCM1)

ATU-PVT-PCM1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243251
Basic UDI-DI: 761333603388BH
Reference: 09527214001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

cobas universal interface

ATU-PVT-PPS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243244
Basic UDI-DI: 761333603387BF
Reference: 09817972001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

CCM Vertical Power Box Unit

ATU-PVT-GPB

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243237
Basic UDI-DI: 761333603386BD
Reference: 09751513001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

CCM Vertical Turntable Unit

ATU-PVT-GTT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243220
Basic UDI-DI: 761333603385BB
Reference: 09751505001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

CCM Vertical Overhead Conveyor Unit (1.0m)

ATU-PVT-GLC10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243213
Basic UDI-DI: 761333603384B9
Reference: 09751491001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

CCM Vertical Elevator Unit

ATU-PVT-GEL

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243206
Basic UDI-DI: 761333603383B7
Reference: 09751483001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Connection Module to CCM (UCM2)

ATU-PVT-UCM2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243190
Basic UDI-DI: 761333603368BB
Reference: 09411844001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® XL Connection Module for CCM (LCM2)

ATU-PVT-LCM2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243183
Basic UDI-DI: 761333603382B5
Reference: 09511385001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details

Phadia-250 Connector to CCM (PCM2)

ATU-PVT-PCM2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243176
Basic UDI-DI: 761333603381B3
Reference: 09511296001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:03

Manufacturer products Authorised representative products Authorised representative actors View details