Is this your brand? Sign in to claim ownership.

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 5 of 6

Device	Model / Reference	Registries	Class	Status
cobas 8100 automated workflow series Language Pack - Spanish Version 4.4.1.es	09506039036	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Simplified Chinese Version 01-02	09465626001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack-Russian	09432205001	EUDAMED	Class A	Active
cobas pro Transport Belt (4 AU, 2 ISE)	09205730001	EUDAMEDFDA UDI	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.el	09743537001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Portuguese Version 01-02	09465979001	EUDAMED	Class A	Active
CRO for cobas 8100	07440022001	EUDAMED	Class A	Active
cobas e 402 analytical unit	09031553001	EUDAMED	Class A	Active
cobas c 303 analytical unit	09031529001	EUDAMED	Class A	Active
Transport Belt 3	05642094001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - Spanish Version 2.3.1.es	09717838001	EUDAMED	Class A	Active
TLJ300 for cobas 8100	07440103001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Japanese Version 3.2.1.ja_W10	09309438001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack-Chinese	0943222130001	EUDAMED	Class A	Active
BCL for cobas 8100	07123922001	EUDAMED	Class A	Active
Transport Belt 1 (w/o ISE)	05989990001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.ro	09709274001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Czech Version 1.3.1.cs	09465618001	EUDAMED	Class A	Active
cobas 8100 automated workflow series System Software Version 04-10	10649496001	EUDAMED	Class A	Active
2nd BCL for cobas 8100	08010595001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - Portuguese Version 4.7.pt	09985760001	EUDAMED	Class A	Active
TLJ2400 for cobas 8100	07441606001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - Polish Version 2.3.zh	10059940001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - English Version 4.8.en	10107146001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.hu	09743545001	EUDAMED	Class A	Active
HST Connection Unit	09511148001	EUDAMED	Class A	Active
Laser BCR modification kit for UCU	08433097001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - Spanish Version 4.6.1.es	09857095001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.fr	09465553001	EUDAMED	Class A	Active
cobas 8000 Tube rotation	05964059 001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack - Russian Version 3.2.1.ru	09309454001	EUDAMED	Class A	Active
AOB for cobas 8100	07123914001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - German Version 1.3.1.de	09756825001	EUDAMED	Class A	Active
TLJ900 for cobas 8100	07440120001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - English Version 6.9.1.en	09720162001	EUDAMED	Class A	Active
Conveyor 1 Unit (0, 5m)	09511024001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - French Version 2.3.1.fr	09717897001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.pl	09743561001	EUDAMED	Class A	Active
Laser BCR modification kit for OBS	08433089001	EUDAMED	Class A	Active
CCM Bidirectional Unit	09511717001	EUDAMED	Class A	Active
TLJ1500 for cobas 8100	07440146001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - English Version 4.6.1.en	09857044001	EUDAMED	Class A	Active
CLO for cobas 8100	07439997001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - Chinese Version 6.9.1.zh	09720073001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.et	09743553001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Latvian Version 3.2.1 lv	09742956001	EUDAMED	Class A	Active
CCM Vertical Elevator Unit	09751483001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - Romanian Version 4.10.ro	10652845001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - French Version 6.10.fr	09976345001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - English Version 2.2.1 en	09515917001	EUDAMED	Class A	Active

Related Companies

Authorised Representatives

Roche Diagnostics GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.