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: Hajime Isaka
EUDAMED SRN: JP-MF-000016991
FDA FEI Number: —
DUNS Number: —

Catalogue (277)

Page 4 of 6

Device	Model / Reference	Registries	Class	Status
cobas pro integrated solutions System Software Version 02-02	09400915001	EUDAMED	Class A	Active
SCM for cobas 8100	07440073001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Bulgarian Version 3.2.1 bg	09650571001	EUDAMED	Class A	Active
TLJ1200 for cobas 8100	07440138001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack – Portuguese Version 4.5.1.pt	09722050001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Polish Version 3.2.1.pl	09309446001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - German Version 2.3.1.de	09717927001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - English Version 2.3.1.en	09717862001	EUDAMED	Class A	Active
Linear Buffer Unit	09511172001	EUDAMED	Class A	Active
Phadia-250 Connector to CCM (PCM2)	09511296001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series Language Pack - Portuguese Version 6.10.pt	09976361001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - French Version 4.5.1.fr	09722041001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Polish Version 01-02	09465600001	EUDAMED	Class A	Active
cobas 8100 automated workflow series Language Pack - Italian Version 4.8.it	10107189001	EUDAMED	Class A	Active
cobas pro Transport Line	09205683001	EUDAMEDFDA UDI	Class A	Active
cobas pro integrated solutions Language Pack - Italian Version 2.3.it	09956077001	EUDAMED	Class A	Active
cobas c 513 analyzer Language Pack -Spanish Version: 2.6.es	10073683001	EUDAMED	Class A	Active
Aliquot Tips 2000	07084307001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – French Version 3.2.2.fr	09650601001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.bg	09709282001	EUDAMED	Class A	Active
TLJ2700 for cobas 8100	07441614001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - Japanese Version 2.3.ja	09956093001	EUDAMED	Class A	Active
3000m Liq.Fl.Path Mod.kit e801	09075704001	EUDAMED	Class A	Active
Signal Tower	07474652001	EUDAMED	Class A	Active
Turn Unit	09511113001	EUDAMED	Class A	Active
2nd IPB for cobas 8100	08015597001	EUDAMED	Class A	Active
cobas 6500 URF Modification Kit	08260125001	EUDAMED	Class A	Active
cobas 8000 modular analyzer series System Software Version :06-08	09432078001	EUDAMED	Class A	Active
cobas c 311 analyzer	04826876001	EUDAMEDFDA UDI	Class A	Active
cobas 8100 automated workflow series Language Pack - French Version 4.6.1.fr	09857052001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Romanian Version 3.2.1.ro	09650580001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Norwegian Version 3.2.1.no	09743103001	EUDAMED	Class A	Active
cobas pro SSU	09205632001	EUDAMEDFDA UDI	Class A	Active
cobas pro integrated solutions Language Pack - French Version 2.2.1 fr	09515933001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Italian Version 01-02	09458644001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack - Polish Version 1.3.1.pl	09756884001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Chinese Version 3.2.1.zh_W10	09309462001	EUDAMED	Class A	Active
cobas pure integrated solutions System Software Version 01-03	09756809001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Italian Version 3.2.2.it	09650636001	EUDAMED	Class A	Active
Laser BCR modification kit for AOB	08433062001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.it	09465545001	EUDAMED	Class A	Active
RFX for cobas 8100	07440065001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.zh	09709266001	EUDAMED	Class A	Active
cobas e 411 analyzer Language Pack – Hungarian Version 3.2.1 hu	09742913001	EUDAMED	Class A	Active
cobas c 311 analyzer Language Pack 1.13.1.ru	09709258001	EUDAMED	Class A	Active
CRW for cobas 8100	07440049001	EUDAMED	Class A	Active
cobas pure integrated solutions Language Pack – Japanese Version 1.3.ja	09957251001	EUDAMED	Class A	Active
cobas pro integrated solutions Language Pack - French Version 2.3.fr	09956042001	EUDAMED	Class A	Active
cobas pro ISE analytical unit	08464537001	EUDAMEDFDA UDI	Class A	Active
cobas 8100 automated workflow series System Software Version 04-04	09506675001	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.