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

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359 device results listed.

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ATU-PVT-TT

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243114
Basic UDI-DI: 761333603375B8
Reference: 09511113001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Output Unit

ATU-PVT-MO1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243107
Basic UDI-DI: 761333603374B6
Reference: 09519041001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

CCM cobas c513 Connection Unit

ATU-PVT-AC6

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243091
Basic UDI-DI: 761333603373B4
Reference: 09511393001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

CCM Bidirectional Unit

ATU-PVT-AC5

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243084
Basic UDI-DI: 761333603372B2
Reference: 09511717001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

HST Connection Unit

ATU-PVT-AC4

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243077
Basic UDI-DI: 761333603371AY
Reference: 09511148001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8000 Connection Unit

ATU-PVT-AC2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243060
Basic UDI-DI: 761333603370AW
Reference: 09511130001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 6000 Connection Unit

ATU-PVT-AC1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243053
Basic UDI-DI: 761333603369BD
Reference: 09511008001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series Language Pack - Spanish Version 4.10.es

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: 07613336241714
Basic UDI-DI: 761333603362AX
Reference: 10652853001
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 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series System Software Version 04-10

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: 07613336240953
Basic UDI-DI: 761333603332AN
Reference: 10649496001
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 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Conveyor 1 Unit (0,5m)

ATU-PVT-LC

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336243015
Basic UDI-DI: 761333603389BK
Reference: 09511024001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Single Tube Holder (Slim)

cobas 8100 automated workflow series

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336228395
Basic UDI-DI: 761333602961BL
Reference: 10165391001
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

c8100 MSC modification kit

cobas 8100 automated workflow series

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336228388
Basic UDI-DI: 761333602960BJ
Reference: 10165375001
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

RFU for cobas 8100

cobas 8100 automated workflow series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336228371
Basic UDI-DI: 761333602959BZ
Reference: 10165367001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series Language Pack - English Version 4.8.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: 07613336227701
Basic UDI-DI: 761333602930B9
Reference: 10107146001
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 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series System Software Version 04-08

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: 07613336227695
Basic UDI-DI: 761333602929BQ
Reference: 10106913001
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 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

cobas c 513 analyzer System Software Version 02-06

cobas c 513 analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336227343
Basic UDI-DI: 761333602948BU
Reference: 10073713001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

cobas c 513 analyzer Language Pack -Chinese Version 2.6.zh

cobas c 513 analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336227282
Basic UDI-DI: 761333602949BW
Reference: 10073659001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

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, Ltd.
Manufacturer SRN: JP-MF-000018582
UDI-DI: 07613336225004
Basic UDI-DI: 761333602977C3
Reference: 9817972001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series Language Pack - English Version 4.7.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: 07613336224724
Basic UDI-DI: 761333602797BX
Reference: 09985743001
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 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series System Software Version 04-07

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: 07613336224717
Basic UDI-DI: 761333602796BV
Reference: 09985735001
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 06:02

Manufacturer products Authorised representative products Authorised representative actors View details