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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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330 device results listed.

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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

cobas e 411 analyzer (rack system)

cobas e 411 analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630924721
Basic UDI-DI: 7613336013209Z
Reference: 04775279001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
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

Micro Sample Cup

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630924141
Basic UDI-DI: 761333601782BB
Reference: 11229290001
EMDN: W02079080
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - 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

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

TLJ600 for cobas 8100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630943944
Basic UDI-DI: 761333602179AX
Reference: 07440111001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 23.06.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

TLJ900 for cobas 8100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630943951
Basic UDI-DI: 761333602179AX
Reference: 07440120001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 23.06.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

TLJ1200 for cobas 8100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630943968
Basic UDI-DI: 761333602179AX
Reference: 07440138001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 23.06.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

TLJ1500 for cobas 8100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630943975
Basic UDI-DI: 761333602179AX
Reference: 07440146001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 23.06.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

TLJ1800 for cobas 8100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630943982
Basic UDI-DI: 761333602179AX
Reference: 07441541001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 23.06.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

TLJ2100 for cobas 8100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630943999
Basic UDI-DI: 761333602179AX
Reference: 07441592001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 23.06.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

TLJ2400 for cobas 8100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630944002
Basic UDI-DI: 761333602179AX
Reference: 07441606001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 23.06.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

TLJ2700 for cobas 8100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630944019
Basic UDI-DI: 761333602179AX
Reference: 07441614001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 23.06.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

TLJ3000 for cobas 8100

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630944026
Basic UDI-DI: 761333602179AX
Reference: 07441622001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Roche Diagnostics GmbH
Last updated: 23.06.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

c8100 HHT 2 tray IPB/OBS mod kit

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336146910
Basic UDI-DI: 761333602187AW
Reference: 08137579001
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE 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

c8100 Sysmex Tray OBS mod kit

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336146927
Basic UDI-DI: 761333602187AW
Reference: 08137633001
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE 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

c8100 100 pos Tray IPB/OBS mod kit

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336146941
Basic UDI-DI: 761333602187AW
Reference: 08137200001
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE 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

c8100 HHT +1 tray IPB/OBS mod kit

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336146958
Basic UDI-DI: 761333602187AW
Reference: 08137595001
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE 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

Laser BCR modification kit for URF

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336169605
Basic UDI-DI: 761333602189B2
Reference: 08433038001
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE 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

Laser BCR modification kit for RFX

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 07613336169612
Basic UDI-DI: 761333602189B2
Reference: 08433046001
EMDN: W02069080
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - HARDWARE 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