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EUDAMED Device Search

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

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01.08.2026 06:24

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80 device results listed.

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STANDARD™ LMS (Lipid Management Software)

02LMS10

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingSelf testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724831
Basic UDI-DI: 88001117IAAA01PA14L7
Reference: 02LMS10
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ DMS (Diabetes Management Software)

01DMS10

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingSelf testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724824
Basic UDI-DI: 88001117IAAA01PA15L9
Reference: 01DMS10
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Pic Diabetes Management

99DMS30

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingSelf testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724817
Basic UDI-DI: 88001117IAAA02PA15LL
Reference: 99DMS30
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoNavii® App

G-APP-01

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingSelf testing

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724800
Basic UDI-DI: 88001117IAAA01PA16LB
Reference: 01APP10
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

cobas c 513 analyzer System Software Version 02-06

cobas c 513 analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336227343
Basic UDI-DI: 761333602948BU
Reference: 10073713001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - 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 c 513 analyzer Language Pack -Chinese Version 2.6.zh

cobas c 513 analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336227282
Basic UDI-DI: 761333602949BW
Reference: 10073659001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - 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 8000 modular analyzer series System Software Version 06-10

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: 07613336224489
Basic UDI-DI: 761333602777BR
Reference: 09976418001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - 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 8000 modular analyzer series Language Pack - German Version 6.10.de

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: 07613336224403
Basic UDI-DI: 761333602778BT
Reference: 09976264001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - 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 pure integrated solutions Language Pack - English Version 1.3.1.en

cobas pure integrated solutions

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336218525
Basic UDI-DI: 761333602635B4
Reference: 09756817001
EMDN: W0201010182
EMDN description: CHEMISTRY 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 pure integrated solutions System Software Version 01-03

cobas pure integrated solutions

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336218518
Basic UDI-DI: 761333602640AV
Reference: 09756809001
EMDN: W0201010182
EMDN description: CHEMISTRY 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 System Software Version 02-03

cobas pro integrated solutions

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336217900
Basic UDI-DI: 761333602639BC
Reference: 09719385001
EMDN: W0201010182
EMDN description: CHEMISTRY 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 Language Pack - Chinese Version 6.9.1.zh

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: 07613336215852
Basic UDI-DI: 761333602638BA
Reference: 09720073001
EMDN: W0201010182
EMDN description: CHEMISTRY 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 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

cobas pure integrated solutions Language Pack - French Version 01-02

-

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336188279
Basic UDI-DI: 761333602146AG
Reference: 09458646001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 16.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

cobas pure integrated solutions Language Pack - Italian Version 01-02

-

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336188286
Basic UDI-DI: 761333602146AG
Reference: 09458644001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 16.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

cobas pure integrated solutions Language Pack - Spanish Version 01-02

-

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336188293
Basic UDI-DI: 761333602146AG
Reference: 09458697001
EMDN: W0201010182
EMDN description: CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 16.06.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details