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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

07332699000607

ISCUS flex Microdialysis Analyzer

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentMicrobial substancesNear-patient testingProfessional testing

Manufacturer: M Dialysis AB
Manufacturer SRN: SE-MF-000017466
UDI-DI: 07332699000607
Basic UDI-DI: 7332699_300_001_UZ
Reference: 8003295
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:09

Manufacturer products View details

17290017272402

Minuteful - kidney test

IVD Class CIVDR 2017/746Not intended for EU marketDirect markingNear-patient testingSelf testingSingle use

Manufacturer: Healthy.io
Manufacturer SRN: IL-MF-000023029
UDI-DI: 17290017272402
Basic UDI-DI: 729001727240AT
Reference: MNT KDN.EN.GEN
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: -
Safety summary (SSCP/SSP): MNT-KT-EU-SSP-01 · Rev. 2
Authorised representative: AR Experts B.V.
Last updated: 03.07.2026 01:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Auto Dry Biochemistry Analyzer

SD1080

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020372
Basic UDI-DI: 6978848020372HJ
Reference: A00814000EN0
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details