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

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356 device results listed.

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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: 07613336101247
Basic UDI-DI: 761333602168AS
Reference: 07787120001
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

cobas 8000 ISE 1800 Module

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: 04015630946341
Basic UDI-DI: 761333601394AW
Reference: 05964075001
EMDN: W0201010108
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

cobas c 513 analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630946327
Basic UDI-DI: 761333601501A7
Reference: 07649142001
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

UCU 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: 04015630944064
Basic UDI-DI: 761333602180AG
Reference: 07476124001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Connection kit STA-R

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: 04015630944057
Basic UDI-DI: 761333602184AQ
Reference: 07474687001
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 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Signal Tower

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: 04015630944040
Basic UDI-DI: 761333602186AU
Reference: 07474652001
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 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

URF 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: 04015630944033
Basic UDI-DI: 761333602181AJ
Reference: 07441657001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

TLJ300 for cobas 8100

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: 04015630943937
Basic UDI-DI: 761333602179AX
Reference: 07440103001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

SLR 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: 04015630943920
Basic UDI-DI: 761333602178AV
Reference: 07440090001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

SLL 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: 04015630943913
Basic UDI-DI: 761333602177AT
Reference: 07440081001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

SCM 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: 04015630943906
Basic UDI-DI: 761333602176AR
Reference: 07440073001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

RFX 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: 04015630943890
Basic UDI-DI: 761333602173AK
Reference: 07440065001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

PXT 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: 04015630943883
Basic UDI-DI: 761333602171AF
Reference: 07440057001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

CRW 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: 04015630943876
Basic UDI-DI: 761333602166AN
Reference: 07440049001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

CRO 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: 04015630943869
Basic UDI-DI: 761333602165AL
Reference: 07440022001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

BRF 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: 04015630943838
Basic UDI-DI: 761333602162AE
Reference: 07439954001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

BCL Screw Top Tube 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: 04015630943807
Basic UDI-DI: 761333602183AN
Reference: 07123957001
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 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

CLW 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: 04015630943852
Basic UDI-DI: 761333602164AJ
Reference: 07440006001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

CLO 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: 04015630943845
Basic UDI-DI: 761333602163AG
Reference: 07439997001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

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: 04015630943791
Basic UDI-DI: 761333602160AA
Reference: 07123922001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details