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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 6 of 6

Device	Model / Reference	Registries	Class	Status
cobas e 411 analyzer Language Pack – Spanish Version 3.2.2.es	09650628001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - Japanese Version 6.10.ja	09976396001	EUDAMED	Class A	Active
URF for cobas 8100	07441657001	EUDAMED	Class A	Active
UCU for cobas 8100	07476124001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - Italian Version 6.9.1.it	09720120001	EUDAMED	Class A	Active
Laser BCR modification kit for RFX	08433046001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - Italian Version 2.2.1 it	09515941001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Czech Version 01-02	09465618001	EUDAMED	Class A	Active
CCM Backend Connection Unit	09519122001	EUDAMED	Class A	Active
BCL Screw Top Tube Modification Kit	07123957001	EUDAMED	Class A	Active
SLR for cobas 8100	07440090001	EUDAMED	Class A	Active
OBS for cobas 8100	07123892001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack – German Version 1.3.de	09957138001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack – Italian Version 1.3.it	09957197001	EUDAMED	Class A	Active
cobas pro integrated solutions System Software Version 02-03	09719385001	EUDAMED	Class A	Active
Output Unit	09519041001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.pt	09465537001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - French Version 4.8.fr	10107154001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack – Chinese Version 1.3.zh	09957316001	EUDAMED	Class A	Active
cobas c 513 analyzer Language Pack -English Version 2.6.en	10073705001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Greek Version 3.2.1 el	09742263001	EUDAMED	Class A	Active
CCM Vertical Turntable Unit	09751505001	EUDAMED	Class A	Active
cobas 8100 automated workflow series System Software Version 04-05	09722017001	EUDAMED	Class A	Active
cobas 8100 automated workflow series System Software Version 04-06	09857036001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - Spanish Version 4.8.es	10107197001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - German Version 4.10.de	10652896001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - German Version 4.5.1.de	09722084001	EUDAMED	Class A	Active

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