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

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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 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

HHT-LLD SCM retrofit 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: 07613336224274
Basic UDI-DI: 761333602798BZ
Reference: 09968563001
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

cobas 8100 automated workflow series Language Pack - English Version 4.6.1.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: 07613336222058
Basic UDI-DI: 761333602692BG
Reference: 09857044001
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 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series System Software Version 04-06

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: 07613336222041
Basic UDI-DI: 761333602691BE
Reference: 09857036001
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 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series System Software Version 04-05

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: 07613336216422
Basic UDI-DI: 761333602580B4
Reference: 09722017001
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 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series Language Pack - English Version 4.5.1.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: 07613336216439
Basic UDI-DI: 761333602581B6
Reference: 09722025001
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 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series Language Pack - English Version 4.4.1.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: 07613336203415
Basic UDI-DI: 761333602197AZ
Reference: 09506039018
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 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8100 automated workflow series System Software Version 04-04

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: 07613336203408
Basic UDI-DI: 761333602196AX
Reference: 09506675001
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 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

Laser BCR modification kit for BRF

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: 07613336169599
Basic UDI-DI: 761333602189B2
Reference: 08433020001
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 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

c8100 HHT/Sysmex TrayLane Arm cover

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: 07613336146934
Basic UDI-DI: 761333602188AY
Reference: 08137218001
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 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

c8100 HHT 1 tray IPB/OBS mod 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: 07613336146903
Basic UDI-DI: 761333602187AW
Reference: 08137536001
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 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 6500 URF 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: 07613336148235
Basic UDI-DI: 761333602185AS
Reference: 08260125001
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 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

2nd BCL 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: 07613336142561
Basic UDI-DI: 761333602161AC
Reference: 08010595001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

2nd IPB 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: 07613336142554
Basic UDI-DI: 761333602169AU
Reference: 08015597001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details