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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 1 of 6

Device	Model / Reference	Registries	Class	Status
Phadia-250 Connector to cobas 8100 (PCM1)	09527214001	EUDAMED	Class A	Active
Conveyor 4 Unit (0, 69m)	09511377001	EUDAMED	Class A	Active
Conveyor 2 Unit (1m)	09511032001	EUDAMED	Class A	Active
CCM Address Extension Unit	09519092001	EUDAMED	Class A	Active
Conveyor 3 Unit (0, 31m)	09511369001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - German Version 6.9.1.de	09720154001	EUDAMED	Class A	Active
Reaction Cell c 311	04555040001	EUDAMED	Class A	Active
Reaction Cell c 501 / c 502	04854241001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - Portuguese Version 4.8.pt	10107162001	EUDAMED	Class A	Active
CCM cobas c513 Connection Unit	09511393001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack – Italian Version 4.5.1.it	09722068001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series System Software Version 06-10	09976418001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - Japanese Version 6.9.1.ja	09720090001	EUDAMED	Class A	Active
Reaction Cell c 503 / c 513	07700814001	EUDAMED	Class A	Active
cobas 8000 B-Gate KIT	06372546001	EUDAMED	Class A	Active
TLJ600 for cobas 8100	07440111001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Russian Version 01-02	09465634001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - French Version 6.9.1.fr	09720138001	EUDAMED	Class A	Active
RSS for cobas 8100	08015589001	EUDAMED	Class A	Active
cobas c 513 analyzer Language Pack -Chinese Version 2.6.zh	10073659001	EUDAMED	Class A	Active
cobas 8000 ISE 900 Module	05641497001	EUDAMED	Class A	Active
Transport Belt 2 (w/o ISE)	05990009001	EUDAMED	Class A	Active
cobas 8000 c 702 Module	06473245001	EUDAMEDFDA UDI	Class A	Active
cobas 8100 automated workflow series Language Pack - English Version 4.7.en	09985743001	EUDAMED	Class A	Active
cobas e 801 analytical unit	08454345001	EUDAMED	Class A	Active
Laser BCR modification kit for BRF	08433020001	EUDAMED	Class A	Active
Add-On Buffer Unit	09519050001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - German Version 2.2.1 de	09515925001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.de	09465588001	EUDAMED	Class A	Active
Power Supply Unit	09511083001	EUDAMED	Class A	Active
cobas 8000 Additional ISE KIT	06372546001	EUDAMED	Class A	Active
cobas pro Transport Belt (3 AU, 2 ISE)	09205721001	EUDAMEDFDA UDI	Class A	Active
SLL for cobas 8100	07440081001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - Spanish Version 4.7.es	09985786001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Turkish Version 3.2.1.tr	09743251001	EUDAMED	Class A	Active
ACU for cobas 8100	07123868001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - English Version 1.3.1.en	09756817001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.sk	09743570001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Slovak Version 3.2.1.sk	09743146001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - French Version 01-02	09458646001	EUDAMED	Class A	Active
Reaction Cell c 701 / c 702	04939719001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - German Version 2.3.de	09956026001	EUDAMED	Class A	Active
IPB for cobas 8100	07787120001	EUDAMED	Class A	Active
cobas universal interface	09817972001	EUDAMED	Class A	Active
cobas pro SBL c 503	09205691001	EUDAMEDFDA UDI	Class A	Active
cobas pure liquid waste container	09033394001	EUDAMED	Class A	Active
TLJ1800 for cobas 8100	07441541001	EUDAMED	Class A	Active
Connection kit STA-R	07474687001	EUDAMED	Class A	Active
cobas pro B-Gate Upgrade Kit	09205756001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack-Italian	07613336187197	EUDAMED	Class A	Active

Related Companies

Authorised Representatives

Roche Diagnostics GmbH DE

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