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abioSCOPE

P01.00007

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

Manufacturer: Abionic SA
Manufacturer SRN: CH-MF-000026307
UDI-DI: 07649996894014
Basic UDI-DI: 7649996894P01ANF
Reference: P01.00007
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Greece
Authorised representative: Veranex Germany GmbH
Last updated: 03.07.2026 06:56

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 pro integrated solutions Language Pack - English Version 2.3.1.en

cobas pro integrated solutions

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336217788
Basic UDI-DI: 761333602637B8
Reference: 09717862001
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - 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 8000 modular analyzer series System Software Version 06-09

cobas 8000 modular analyzer series

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336217375
Basic UDI-DI: 761333602508AU
Reference: 09712097001
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - 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 pro integrated solutions Language Pack - English Version 2.2.1 en

cobas pro integrated solutions

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336201145
Basic UDI-DI: 761333602194AT
Reference: 09515917001
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

3000m Liq.Fl.Path Mod.kit e801

cobas pro integrated solutions

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336198391
Basic UDI-DI: 761333601631AM
Reference: 09075704001
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8000 modular analyzer series Language Pack-English

cobas 8000 modular analyzer series

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336187142
Basic UDI-DI: 761333601994BU
Reference: 09432086001
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

cobas pure integrated solutions Instrument Software Version 01-02

cobas pure integrated solutions

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336188248
Basic UDI-DI: 761333602155AH
Reference: 09458115001
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8000 modular analyzer series System Software Version :06-08

cobas 8000 modular analyzer series

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336187135
Basic UDI-DI: 761333601995BW
Reference: 09432078001
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

cobas pro integrated solutions System Software Version 02-02

cobas pro integrated solutions

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336183977
Basic UDI-DI: 761333602195AV
Reference: 09400915001
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

cobas e 411 analyzer Instrument Software Version 03-02

cobas e 411 analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336183762
Basic UDI-DI: 761333601991BN
Reference: 09390090001
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

cobas e 411 analyzer Language Pack – Italian Version 3.2.1.it

cobas e 411 analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336181218
Basic UDI-DI: 7613336020049T
Reference: 09309403001
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

cobas pro B-Gate Upgrade Kit

cobas pro integrated solutions

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336179574
Basic UDI-DI: 761333601780B7
Reference: 09205756001
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8000 Additional ISE KIT

cobas 8000 modular analyzer series

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336172940
Basic UDI-DI: 761333601422AA
Reference: 06372546001
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8000 Tube rotation

cobas 8000 modular analyzer series

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336172933
Basic UDI-DI: 761333601393AU
Reference: 05964059 001
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

cobas pure liquid waste container

cobas pure integrated solutions

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336172599
Basic UDI-DI: 761333601774BC
Reference: 09033394001
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - 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 e 402 analytical unit

cobas pure integrated solutions

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336172506
Basic UDI-DI: 761333601773BA
Reference: 09031553001
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
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 pro liquid waste container

cobas pro integrated solutions

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336164853
Basic UDI-DI: 761333601610AD
Reference: 08763704001
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - 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 pro B-Gate update kit

cobas pro integrated solutions

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336164846
Basic UDI-DI: 761333601609AU
Reference: 08763640001
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - 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 8000 A-Gate Connection KIT

cobas 8000 modular analyzer series

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336164525
Basic UDI-DI: 761333601519AS
Reference: 07996527 001
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - 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