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cobas c 311 analyzer Instrument Software Version 01-13

cobas c 311 analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336188644
Basic UDI-DI: 761333601996BY
Reference: 09465596001
EMDN: W0201010182
EMDN description: CHEMISTRY 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 c 311 analyzer Language Pack 1.13.1.pt

cobas c 311 analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336188583
Basic UDI-DI: 761333601997C2
Reference: 09465537001
EMDN: W0201010182
EMDN description: CHEMISTRY 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 Language Pack - German 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: 07613336188262
Basic UDI-DI: 761333602146AG
Reference: 09458620001
EMDN: W0201010182
EMDN description: CHEMISTRY 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 c 513 analyzer System software installation CD Version 02-05

cobas c 513 analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336187722
Basic UDI-DI: 761333602149AN
Reference: 09440194001
EMDN: W0201010182
EMDN description: CHEMISTRY 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 c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2;5;1

cobas c 513 analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336187739
Basic UDI-DI: 761333602156AK
Reference: 09440208001
EMDN: W0201010182
EMDN description: CHEMISTRY 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

Reaction Cell c 303

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336172605
Basic UDI-DI: 761333601775BE
Reference: 09033408001
EMDN: W0201010180
EMDN description: CHEMISTRY 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 c 303 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: 07613336172483
Basic UDI-DI: 761333601771B6
Reference: 09031529001
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
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 ISE analytical unit

cobas pro integrated solutions

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336158876
Basic UDI-DI: 761333601581AX
Reference: 08464537001
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
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 c 503 analytical unit

cobas pro integrated solutions

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336158784
Basic UDI-DI: 761333601576B6
Reference: 08463662001
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
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

Reaction Cell c 503 / c 513

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336156773
Basic UDI-DI: 761333601511AA
Reference: 07700814001
EMDN: W0201010180
EMDN description: CHEMISTRY 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

B-gate connection kit for cobas c 513 analyzer

cobas c 513 analyzer

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336153987
Basic UDI-DI: 761333601546AV
Reference: 08341621001
EMDN: W0201010180
EMDN description: CHEMISTRY 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 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

Reaction Cell c 311

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630934263
Basic UDI-DI: 761333601280AE
Reference: 04555040001
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8000 c 702 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: 04015630930845
Basic UDI-DI: 761333601421A8
Reference: 06473245001
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 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8000 ISE 900 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: 04015630928347
Basic UDI-DI: 761333601372AL
Reference: 05641497001
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 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

cobas 8000 c 701 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: 04015630928255
Basic UDI-DI: 761333601371AJ
Reference: 05641489001
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 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

Reaction Cell c 701 / c 702

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630927289
Basic UDI-DI: 761333601343AD
Reference: 04939719001
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

cobas c 311 analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630925551
Basic UDI-DI: 761333601323A7
Reference: 04826876001
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

Reaction Cell c 501 / c 502

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630924110
Basic UDI-DI: 761333601327AF
Reference: 04854241001
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details