Manufacturer

Hitachi High-Tech

JapanLegal entities : Hitachi High-Tech Corporation

First countries of placing on the market declared in EUDAMED : Germany, Italy

Public contracts won : Austria 1

EU representative : Roche Diagnostics GmbH (Germany)

ra-contact.aj@hitachi-hightech.com

19 categories, 123 models including 123 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Various sample processing instruments - other	W02069099	2nd BCL for cobas 8100 cobas 8100 automated workflow series 2nd IPB for cobas 8100 cobas 8100 automated workflow series AOB for cobas 8100 cobas 8100 automated workflow series AQM for cobas 8100 cobas 8100 automated workflow series BCL for cobas 8100 cobas 8100 automated workflow series 19 others BRF for cobas 8100 cobas 8100 automated workflow series CLO for cobas 8100 cobas 8100 automated workflow series CLW for cobas 8100 cobas 8100 automated workflow series CRO for cobas 8100 cobas 8100 automated workflow series CRW for cobas 8100 cobas 8100 automated workflow series DSP for cobas 8100 cobas 8100 automated workflow series IPB for cobas 8100 cobas 8100 automated workflow series OBS for cobas 8100 cobas 8100 automated workflow series PXT for cobas 8100 cobas 8100 automated workflow series RFU for cobas 8100 cobas 8100 automated workflow series RFX for cobas 8100 cobas 8100 automated workflow series RSF for cobas 8100 cobas 8100 automated workflow series RSS for cobas 8100 cobas 8100 automated workflow series SCM for cobas 8100 cobas 8100 automated workflow series SLL for cobas 8100 cobas 8100 automated workflow series SLR for cobas 8100 cobas 8100 automated workflow series TLJ1200 for cobas 8100 cobas 8100 automated workflow series3 refs UCU for cobas 8100 cobas 8100 automated workflow series URF for cobas 8100 cobas 8100 automated workflow series	A IVDR	EUDAMED record Report an error
IVD instruments - other	W0299	Add-On Buffer Unit ATU-PVT-AOB CCM Address Extension Unit ATU-PVT-SBM1 CCM Backend Connection Unit ATU-PVT-BCU2 CCM Bidirectional Unit ATU-PVT-AC5 CCM cobas c513 Connection Unit ATU-PVT-AC6 17 others CCM Vertical Elevator Unit ATU-PVT-GEL CCM Vertical Overhead Conveyor Unit (1.0m) ATU-PVT-GLC10 CCM Vertical Power Box Unit ATU-PVT-GPB CCM Vertical Turntable Unit ATU-PVT-GTT cobas 6000 Connection Unit ATU-PVT-AC1 cobas 8000 Connection Unit ATU-PVT-AC2 cobas universal interface ATU-PVT-PPS Conveyor 1 Unit (0,5m) ATU-PVT-LC3 refs HST Connection Unit ATU-PVT-AC4 LIAISON® XL Connection Module for CCM (LCM2) ATU-PVT-LCM2 Linear Buffer Unit ATU-PVT-LBF05 Output Unit ATU-PVT-MO1 Phadia-250 Connector to CCM (PCM2) ATU-PVT-PCM2 Phadia-250 Connector to cobas 8100 (PCM1) ATU-PVT-PCM1 Power Supply Unit ATU-PVT-PB Turn Unit ATU-PVT-TT Universal Connection Module to CCM (UCM2) ATU-PVT-UCM2	A IVDR	EUDAMED record Report an error
Integrated / modular chemistry / immunochemistry instruments - other	W02010399	cobas 8000 Core Unit cobas 8000 modular analyzer series cobas 8000 Transport Line cobas 8000 modular analyzer series cobas pro SB cobas pro integrated solutions cobas pro SBL c 503 cobas pro integrated solutions cobas pro SBL e 801 cobas pro integrated solutions 12 others cobas pro SSU cobas pro integrated solutions cobas pro Transport Belt (2 AU, 2 ISE) cobas pro integrated solutions3 refs cobas pro Transport Line cobas pro integrated solutions sample supply unit cobas pure integrated solutions Transport Belt 1 (w/o ISE) cobas 8000 modular analyzer series Transport Belt 1 cobas 8000 modular analyzer series Transport Belt 2 (w/o ISE) cobas 8000 modular analyzer series Transport Belt 2 cobas 8000 modular analyzer series Transport Belt 3 (w/o ISE) cobas 8000 modular analyzer series Transport Belt 3 cobas 8000 modular analyzer series Transport Belt 4 (w/o ISE) cobas 8000 modular analyzer series Transport Belt 4 cobas 8000 modular analyzer series	A IVDR	EUDAMED record Report an error
Various sample processing instruments - software accessories	W02069082	cobas 8100 automated workflow series Language Pack - English Version 4.10.en3 refs cobas 8100 automated workflow series Language Pack - English Version 4.11.en3 refs cobas 8100 automated workflow series Language Pack - English Version 4.4.1.en3 refs cobas 8100 automated workflow series Language Pack - English Version 4.5.1.en3 refs cobas 8100 automated workflow series Language Pack - English Version 4.6.1.en3 refs 9 others cobas 8100 automated workflow series Language Pack - English Version 4.7.en3 refs cobas 8100 automated workflow series Language Pack - English Version 4.8.en3 refs cobas 8100 automated workflow series System Software Version 04-04 cobas 8100 automated workflow series System Software Version 04-05 cobas 8100 automated workflow series System Software Version 04-06 cobas 8100 automated workflow series System Software Version 04-07 cobas 8100 automated workflow series System Software Version 04-08 cobas 8100 automated workflow series System Software Version 04-10 cobas 8100 automated workflow series System Software Version 04-11	A IVDR	EUDAMED record Report an error
Various sample processing instruments - hardware accessories	W02069080	Aliquot Tips 2000 Automated Tip Loader BCL Screw Top Tube Modification Kit cobas 8100 automated workflow series c8100 100 pos Tray IPB/OBS mod kit cobas 8100 automated workflow series3 refs c8100 HHT/Sysmex TrayLane Arm cover cobas 8100 automated workflow series 7 others c8100 MSC modification kit cobas 8100 automated workflow series cobas 6500 URF Modification Kit cobas 8100 automated workflow series Connection kit STA-R cobas 8100 automated workflow series HHT-LLD SCM retrofit kit cobas 8100 automated workflow series Laser BCR modification kit for ACU cobas 8100 automated workflow series3 refs Signal Tower cobas 8100 automated workflow series Single Tube Holder (Slim) cobas 8100 automated workflow series	A IVDR	EUDAMED record Report an error
Chemistry analysers - hardware accessories	W0201010180	B-gate connection kit for cobas c 513 analyzer Reaction Cell c 303 Reaction Cell c 311 Reaction Cell c 501 / c 502 Reaction Cell c 503 / c 513 2 others Reaction Cell c 701 / c 702 Reaction Cell for c 703	A IVDR	EUDAMED record Report an error
Chemistry analysers - software accessories	W0201010182	cobas c 311 analyzer Instrument Software Version 01-13 cobas c 311 analyzer Language Pack 1.13.1.bg3 refs cobas c 513 analyzer Internationalization CD DE, EN, ES, FR. PT, ZH Version 2;5;1 cobas c 513 analyzer Language Pack -Chinese Version 2.6.zh3 refs cobas c 513 analyzer System software installation CD Version 02-05 1 other cobas c 513 analyzer System Software Version 02-06	A IVDR	EUDAMED record Report an error
Chemistry analysers - high routine (with ise mode test/h > 1.200)	W0201010108	cobas 8000 c 701 Module cobas 8000 modular analyzer series cobas 8000 c 702 Module cobas 8000 modular analyzer series cobas 8000 ISE 1800 Module cobas 8000 modular analyzer series cobas 8000 ISE 900 Module cobas 8000 modular analyzer series	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - hardware accessories	W0201020180	3000m Liq.Fl.Path Mod.kit e801 cobas pro integrated solutions cobas pure liquid waste container cobas pure integrated solutions	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	cobas e 411 analyzer (disk system) cobas e 411 analyzer (rack system)	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h)	W0201020103	cobas e 801 analytical unit cobas 8000 modular analyzer series cobas e 801 MSB/MSBL cobas 8000 modular analyzer series	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - software accessories	W0201020182	cobas e 411 analyzer Instrument Software Version 03-02 cobas e 411 analyzer Language Pack - Russian Version 3.2.1.ru3 refs	A IVDR	EUDAMED record Report an error
Chemistry analysers - moderate routine (with ise mode test/h > 400 and <= 800)	W0201010106	cobas c 303 analytical unit cobas pure integrated solutions cobas c 311 analyzer	A IVDR	EUDAMED record Report an error
Chemistry analysers - moderate to high routine (with ise mode test/h > 800 and <= 1.200)	W0201010107	cobas c 503 analytical unit cobas pro integrated solutions cobas pro ISE analytical unit cobas pro integrated solutions	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	cobas e 402 analytical unit cobas pure integrated solutions	A IVDR	EUDAMED record Report an error
Centrifuges	W02069003	ACU for cobas 8100 cobas 8100 automated workflow series	A IVDR	EUDAMED record Report an error
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800)	W0201010102	cobas c 513 analyzer	A IVDR	EUDAMED record Report an error
Proton therapy systems	Z11011001	Proton Therapy System PROBEAT-LL	IIb MDR	EUDAMED record Report an error
Various general purpose IVD instruments - hardware accessories	W02079080	Micro Sample Cup	A IVDR	EUDAMED record Report an error

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