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Hitachi High-Tech Corporation

Japan·JP-MF-000016991

Last updated June 8, 2026

Information

Country: Japan
Address: 1-17-1 Toranomon, Minato-ku, , Tokyo , Japan
Website: hitachi-hightech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Hajime Isaka
EUDAMED SRN: JP-MF-000016991
FDA FEI Number: —
DUNS Number: —

Catalogue (277)

Page 3 of 6

Device	Model / Reference	Registries	Class	Status
cobas c 311 analyzer Language Pack 1.13.1.sv	09743588001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - French Version 1.3.1.fr	09756833001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – English version 3.2.1.en	09313907001	EUDAMED	Class A	Active
cobas 8100 automated workflow series System Software Version 04-07	09985735001	EUDAMED	Class A	Active
Laser BCR modification kit for URF	08433038001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - Italian Version 6.10.it	09976353001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - English Version 4.10.en	10652900001	EUDAMED	Class A	Active
cobas pro A-Gate Upgrade Kit	09813799001	EUDAMED	Class A	Active
PXT for cobas 8100	07440057001	EUDAMED	Class A	Active
Reaction Cell c 303	09033408001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - German Version 6.10.de	09976264001	EUDAMED	Class A	Active
CCM Vertical Overhead Conveyor Unit (1.0m)	09751491001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.en	09465570001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack-Japanese	09432191001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Czech Version 3.2.1 cs	09309489001	EUDAMED	Class A	Active
BRF for cobas 8100	07439954001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - Spanish Version 2.2.1 es	09515976001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - Spanish Version 6.9.1.es	09720146001	EUDAMED	Class A	Active
cobas pro Transport Belt (2 AU, 2 ISE)	09205713001	EUDAMEDFDA UDI	Class A	Active
Single Tube Holder (Slim)	10165391001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – French Version 3.2.1.fr	09388079001	EUDAMED	Class A	Active
c8100 Sysmex Tray OBS mod kit	08137633001	EUDAMED	Class A	Active
c8100 HHT/Sysmex TrayLane Arm cover	08137218001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack-French	09432116001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - Spanish Version 2.3.es	09956034001	EUDAMED	Class A	Active
cobas e 411 analyzer (disk system)	04775201001	EUDAMEDFDA UDI	Class A	Active
cobas 8100 automated workflow series Language Pack - German Version 4.7.de	09985794001	EUDAMED	Class A	Active
B-gate connection kit for cobas c 513 analyzer	08341621001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - Japanese Version 2.3.1.jp	09783601001	EUDAMED	Class A	Active
cobas 8000 ISE 1800 Module	05964075001	EUDAMEDFDA UDI	Class A	Active
TLJ3000 for cobas 8100	07441622001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Lithuanian Version 3.2.1 lt	09742999001	EUDAMED	Class A	Active
CCM Vertical Power Box Unit	09751513001	EUDAMED	Class A	Active
c8100 HHT 2 tray IPB/OBS mod kit	08137579001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - English Version 4.5.1.en	09722025001	EUDAMED	Class A	Active
cobas 8100 automated workflow series System Software Version 04-11	10716134001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - Portuguese Version 2.2.1 pt	09515950001	EUDAMED	Class A	Active
cobas pure integrated solutions Instrument Software Version 01-02	09458115001	EUDAMED	Class A	Active
cobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2;5;1	09440208001	EUDAMED	Class A	Active
c8100 HHT 1 tray IPB/OBS mod kit	08137536001	EUDAMED	Class A	Active
cobas pro liquid waste container	08763704001	EUDAMED	Class A	Active
cobas e 411 analyzer (rack system)	04775279001	EUDAMEDFDA UDI	Class A	Active
c8100 MSC modification kit	10165375001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack – Italian Version 4.4.1.it	09505881001	EUDAMED	Class A	Active
Transport Belt 4	05642116001	EUDAMED	Class A	Active
cobas 8000 Core Unit	05641446001	EUDAMEDFDA UDI	Class A	Active
Reaction Cell for c 703	09796762001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Spanish Version 1.3.1.es	09756841001	EUDAMED	Class A	Active
cobas c 311 analyzer Instrument Software Version 01-13	09465596001	EUDAMED	Class A	Active
cobas 6000 Connection Unit	09511008001	EUDAMED	Class A	Active

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Authorised Representatives

Roche Diagnostics GmbH DE

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