IVD instrumentsChemistry / immunochemistry instruments

Integrated / modular chemistry / immunochemistry instruments

EMDN code W020103

10 manufacturers, 21 models including 21 on the market, 4 countries

On the market in Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 10

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

Manufacturer	Country	Registered models	Class	Contact
I.S.E. - Societa' A Responsabilita' Limitata - Sistemi Intelligenti Elettronici	Italy	AUTOANALYZER MOD. HEMO ONE p/n 11154-10-A AUTOANALYZER MOD. MIURA 200 DA (31 Rgt Pos) p/n 10997-00-A2 refs AUTOANALYZER MOD. MIURA 200 SA (31 Rgt Pos) p/n 11025-00-A2 refs AUTOANALYZER MOD. MIURA DA (59 Smp Pos) p/n 10001-02-A2 refs AUTOANALYZER MOD. MIURA ONE (15 Smp Pos) p/n 10750-02-A2 refs	A IVDR	Website info@logotech-ise.com EUDAMED record Report an error
Arkray FDA EU representative : ARKRAY Europe, B.V. (Netherlands)	Japan	SPOTCHEM D-01 (SD-3810)2 refs SPOTCHEM D-02 (SD-4810)2 refs SPOTCHEM D-03 (SD-4820)2 refs	A IVDR, 98/79	support_arkrayeurope@arkray.co.jp EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other	China	DIRUI 1 biochemistry module + 1 immunoassay module + 1 sample unit +1ISE module+ 1 detergent proportioning module + 1 computer & cart98/79 Integrated System CSM-80002 refs98/79 Integrated System CSM-900098/79	– 98/79	EUDAMED record Report an error
Ortho-Clinical Diagnostics Rochester EU representative : Ortho-Clinical Diagnostics France (France)	United States	VITROS 5600 Integrated System2 refs VITROS XT 3400 VITROS XT 76002 refs	A IVDR	Website PRRC@quidelortho.com EUDAMED record Report an error
Bioendo EU representative : JOYSUN GROUP S.L.U (Spain)	China	Intelligent Fully Automatic Endotoxin And MAT Detection Robot System (Phoenix Q Series) Phoenix Q5 Intelligent Fully Automatic Endotoxin Detection Robot System (Qilin Endomaster Series)	A IVDR	sale@bioendo.com EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Metis 6000 Modular System (Integrated Clinical Chemistry and Immunochemistry)	A IVDR	EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Specific Protein Analyzer Please see UDI-DI for detail	A IVDR	Website EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United States	Atellica CI Analyzer IVDR_67_TTN_DUB-C_A_INST_Atellica CI 1900 Analyzer	A IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Sunlant EU representative : MedPath GmbH (Germany)	China	Automatic Biochip Analyzer	A IVDR	EUDAMED record Report an error
Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Real-Time PCR Fluorescent Quantitative Analyzer UKRT Qube / UKRT Mini / UKRT 320 / UKRT 9603 refs	A IVDR	sales@ukinbio.com EUDAMED record Report an error

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