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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: Hideki Higashizono
EUDAMED SRN: JP-MF-000016991
FDA FEI Number: —
DUNS Number: —

Catalogue (277)

Page 2 of 6

Device	Model / Reference	Registries	Class	Status
cobas e 801 MSB/MSBL	08459606 001	EUDAMEDFDA UDI	Class A	Active
cobas pro integrated solutions Language Pack - Portuguese Version 2.3.1.pt	09717919001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Estonian Version 3.2.1.et	09743049001	EUDAMED	Class A	Active
RSF for cobas 8100	07123876001	EUDAMED	Class A	Active
RFU for cobas 8100	10165367001	EUDAMED	Class A	Active
DSP for cobas 8100	07787146001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – German Version 3.2.2.de	09650610001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.es	09465561001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Danish Version 3.2.1 da	09309497001	EUDAMED	Class A	Active
Automated Tip Loader	07050763001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.tr	09743596001	EUDAMED	Class A	Active
cobas c 513 analyzer System software installation CD Version 02-05	09440194001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack-Spanish	09432108001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - German Version 01-02	09458620001	EUDAMED	Class A	Active
cobas 8000 A-Gate Connection KIT	07996527 001	EUDAMED	Class A	Active
cobas c 503 analytical unit	08463662001	EUDAMEDFDA UDI	Class A	Active
cobas e 411 analyzer Language Pack – Portuguese Version 3.2.2.pt	09650644001	EUDAMED	Class A	Active
cobas 8100 automated workflow series System Software Version 04-08	10106913001	EUDAMED	Class A	Active
cobas e 411 analyzer Instrument Software Version 03-02	09390090001	EUDAMED	Class A	Active
cobas c 513 analyzer Language Pack -French Version 2.6.fr	10073675001	EUDAMED	Class A	Active
cobas pro SBL e 801	09211888001	EUDAMEDFDA UDI	Class A	Active
cobas c 513 analyzer Language Pack -Portuguese Version 2.6.pt	10073667001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - Czech Version 2.3.cs	09956107001	EUDAMED	Class A	Active
TLJ2100 for cobas 8100	07441592001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Japanese Version 01-02	09465642001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Swedish Version 3.2.1.sv	09743227001	EUDAMED	Class A	Active
cobas 8000 Connection Unit	09511130001	EUDAMED	Class A	Active
cobas c 513 analyzer	07649142001	EUDAMEDFDA UDI	Class A	Active
LIAISON® XL Connection Module for CCM (LCM2)	09511385001	EUDAMED	Class A	Active
cobas c 513 analyzer System Software Version 02-06	10073713001	EUDAMED	Class A	Active
c8100 100 pos Tray IPB/OBS mod kit	08137200001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series System Software Version 06-09	09712097001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Spanish Version 01-02	09458697001	EUDAMED	Class A	Active
sample supply unit	09031537001	EUDAMED	Class A	Active
cobas pro SB	09205675001	EUDAMEDFDA UDI	Class A	Active
cobas pure integrated solutions Language Pack - English Version 01-02	09465952001	EUDAMED	Class A	Active
cobas pro B-Gate update kit	08763640001	EUDAMEDFDA UDI	Class A	Active
Laser BCR modification kit for ACU	08433054001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack – English Version 1.3.en	09957120001	EUDAMED	Class A	Active
cobas 8000 c 701 Module	05641489001	EUDAMEDFDA UDI	Class A	Active
cobas 8000 Transport Line	05641519001	EUDAMED	Class A	Active
Universal Connection Module to CCM (UCM2)	09411844001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Portuguese Version 1.3.1.pt	09756850001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Portuguese Version 3.2.1.pt	09313923001	EUDAMED	Class A	Active
Micro Sample Cup	11229290001	EUDAMED	Class A	Active
AQM for cobas 8100	07787138001	EUDAMED	Class A	Active
HHT-LLD SCM retrofit kit	09968563001	EUDAMED	Class A	Active
Transport Belt 2	05642086001	EUDAMED	Class A	Active
CLW for cobas 8100	07440006001	EUDAMED	Class A	Active
c8100 HHT +1 tray IPB/OBS mod kit	08137595001	EUDAMED	Class A	Active

Related Companies

Authorised Representatives

Roche Diagnostics GmbH DE

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