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Hitachi High-Tech

JaponEntités : Hitachi High-Tech Corporation

Marchés : Allemagne · Autriche · Italie · États-Unis

Autorisations : UE – classe IIb, A · États-Unis (FDA) – 510(k) : 1 · classe I, II · dernière en 2026 · voir sur le site de la FDA

Marchés publics remportés : Autriche 1

Mandataire UE : Roche Diagnostics GmbH (Allemagne)

ra-contact.aj@hitachi-hightech.com

19 catégories, 123 modèles dont 123 en vente, 1 pays

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93/42 Ancienne directive, pas encore certifié selon le règlement MDR
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Catégorie	Code EMDN	Modèles enregistrés	Classe	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 autres 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 réf. UCU for cobas 8100 cobas 8100 automated workflow series URF for cobas 8100 cobas 8100 automated workflow series	A IVDR	Fiche EUDAMED Signaler une erreur
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 autres 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 réf. 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	Fiche EUDAMED Signaler une erreur
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 autres cobas pro SSU cobas pro integrated solutions cobas pro Transport Belt (2 AU, 2 ISE) cobas pro integrated solutions3 réf. 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	Fiche EUDAMED Signaler une erreur
Various sample processing instruments - software accessories	W02069082	cobas 8100 automated workflow series Language Pack - English Version 4.10.en3 réf. cobas 8100 automated workflow series Language Pack - English Version 4.11.en3 réf. cobas 8100 automated workflow series Language Pack - English Version 4.4.1.en3 réf. cobas 8100 automated workflow series Language Pack - English Version 4.5.1.en3 réf. cobas 8100 automated workflow series Language Pack - English Version 4.6.1.en3 réf. 9 autres cobas 8100 automated workflow series Language Pack - English Version 4.7.en3 réf. cobas 8100 automated workflow series Language Pack - English Version 4.8.en3 réf. 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	Fiche EUDAMED Signaler une erreur
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 réf. c8100 HHT/Sysmex TrayLane Arm cover cobas 8100 automated workflow series 7 autres 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 réf. Signal Tower cobas 8100 automated workflow series Single Tube Holder (Slim) cobas 8100 automated workflow series	A IVDR	Fiche EUDAMED Signaler une erreur
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 autres Reaction Cell c 701 / c 702 Reaction Cell for c 703	A IVDR	Fiche EUDAMED Signaler une erreur
Chemistry analysers - software accessories	W0201010182	cobas c 311 analyzer Instrument Software Version 01-13 cobas c 311 analyzer Language Pack 1.13.1.bg3 réf. 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 réf. cobas c 513 analyzer System software installation CD Version 02-05 1 autre cobas c 513 analyzer System Software Version 02-06	A IVDR	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	cobas e 411 analyzer (disk system) cobas e 411 analyzer (rack system)	A IVDR	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur
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 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur
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	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	cobas e 402 analytical unit cobas pure integrated solutions	A IVDR	Fiche EUDAMED Signaler une erreur
Centrifuges	W02069003	ACU for cobas 8100 cobas 8100 automated workflow series	A IVDR	Fiche EUDAMED Signaler une erreur
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800)	W0201010102	cobas c 513 analyzer	A IVDR	Fiche EUDAMED Signaler une erreur
Proton therapy systems	Z11011001	Proton Therapy System PROBEAT-LL	IIb MDR	Fiche EUDAMED Signaler une erreur
Various general purpose IVD instruments - hardware accessories	W02079080	Micro Sample Cup	A IVDR	Fiche EUDAMED Signaler une erreur

Un modèle enregistré dans EUDAMED n'est pas forcément commercialisé dans votre pays. Vérifiez la disponibilité et le marquage CE auprès du fabricant.

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