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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Hitachi High-Tech Corporation — Manufacturer in Japan

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EUDAMED update: Jul 13, 2026

HH

Hitachi High-Tech Corporation

Japan

All roles followed

Views by role

Sources: EUDAMED

Legal information of HHT

Legal name: Hitachi High-Tech Corporation
EU VAT number: Not applicable
SRN (displayed role): JP-MF-000016991
EUDAMED status: Active· registered in 2021
Registered office: 1-17-1 Toranomon, Minato-ku, 105-6409 Tokyo, Japan

Contact details for HHT

Email: ra-contact.aj@hitachi-hightech.com
Address: 1-17-1 TORANOMON, MINATO-KU, 105-6409 TOKYO JAPAN

Data export

Export the 330 devices of HHT

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Medical device manufacturers in EUDAMED

Competent authority for HHT

DE/CA38 - Regierungspräsidium Karlsruhe
GermanyContact the authority →

Certificates of HHT

330Total Devices

145Basic UDI-DIs

1Certificates1 valid · 0 expiring < 12 months

2CountriesEU/EEA placements

Market presence of HHT

Devices placed in 2 countries

Germany329
Italy1

Risk categories of HHT

Executives & regulatory representatives of HHT

7 contacts identified

FUJISAWA Tatsuya
PRRC
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HIGASHIZONO Hideki
PRRC
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ISAKA Hajime
PRRC
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ISAKA Hajime
regulatory compliance with IVDR for medical devices manufactured by Naka Division and Omuta Division of Hitachi High-Tech Corporation.
Hidden
HIGASHIZONO Hideki
regulatory compliance with IVDR for medical devices manufactured by Ome Manufacturing Division of Hitachi High-Tech Corporation.
Hidden
FUJISAWA Tatsuya
Obligations defined in the subparagraph (b) of MDR 2017/745 Article 15, paragraph 3 for Particle Beam Therapy Devices and related accessories.
Hidden
TAKAMATSU Mikimoto
Obligations defined in the subparagraph (a), (c) and (d) of MDR 2017/745 Article 15, paragraph 3 for Particle Beam Therapy Devices and related accessories.
Hidden

Related documents of HHT

Quality management system

Certificate MDR 840787Rev. R000

Issued

Manufacturer

Hitachi High-Tech Corporation

Notified body

BSI Group The Netherlands B.V.

2797

Version

1

Valid from

6/11/2026

Valid until

6/10/2031

Cartography of HHT

Authorised representativeNotified bodiesPeople

BSI Group The Netherlands B.V. — 1 certificate — HHT
Roche Diagnostics GmbH — represents — HHT
Hitachi Europe S.A. — represents — HHT
FUJISAWA Tatsuya — HHT
HIGASHIZONO Hideki — HHT
ISAKA Hajime — HHT

Catalog of HHT

330 devices · 145 families

Filter

cobas e 411 analyzer (disk system)cobas e 411 analyzer1 version
cobas e 411 analyzer (rack system)cobas e 411 analyzer1 version
cobas e 411 analyzer Instrument Software Version 03-02cobas e 411 analyzer1 version
cobas e 411 analyzer Language Packcobas e 411 analyzer31 versions
cobas c 513 analyzer1 version
B-gate connection kit for cobas c 513 analyzercobas c 513 analyzer1 version
cobas c 513 analyzer System software installation CD Version 02-05cobas c 513 analyzer1 version
cobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2;5;1cobas c 513 analyzer1 version
cobas c 311 analyzer1 version
cobas c 311 analyzer Instrument Software Version 01-13cobas c 311 analyzer1 version
cobas c 311 analyzer Language Packcobas c 311 analyzer17 versions
sample supply unitcobas pure integrated solutions1 version
cobas e 402 analytical unitcobas pure integrated solutions1 version
cobas c 303 analytical unitcobas pure integrated solutions1 version
cobas pure liquid waste containercobas pure integrated solutions1 version
cobas pure integrated solutions Language Packcobas pure integrated solutions11 versions
cobas pure integrated solutions Instrument Software Version 01-02cobas pure integrated solutions1 version
cobas 8000 Core Unitcobas 8000 modular analyzer series1 version
cobas 8000 c 701 Modulecobas 8000 modular analyzer series1 version
cobas 8000 c 702 Modulecobas 8000 modular analyzer series1 version
cobas e 801 analytical unitcobas 8000 modular analyzer series1 version
cobas e 801 MSB/MSBLcobas 8000 modular analyzer series1 version
cobas 8000 ISE 900 Modulecobas 8000 modular analyzer series1 version
cobas 8000 ISE 1800 Modulecobas 8000 modular analyzer series1 version
cobas 8000 Transport Linecobas 8000 modular analyzer series1 version

145 families

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