Manufacturer

Infitek

ChinaLegal entities : Infitek Co., Ltd., Infitek Co., Ltd.

Markets : Netherlands · Spain · Türkiye · United States

Approvals : EU – class I, A · United States (FDA) – · class I, II

EU representative : Kingsmead Service B.V. (Netherlands)

info@infitek.com

48 categories, 73 models including 73 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
Cryogenics / frozen	W020702	-86 ℃ Ultra Low Temperature Freezer 2-8℃ Refrigerator Freezer LF Series, LF45 Series, LF25 Series, LF40 Series, LF60 Series, LF150 Series, LF86 Series Portable Refrigerator CLR-1.5 Refrigerator CLR Series, MCFR Series, CR Series, BR4 Series, PR5 Series	I, A IVDR, MDR	EUDAMED record Report an error
IVD instruments - other	W0299	CO2 Incubator3 refs Microplate Incubator Microvolume UV/Vis (Nano)/Nucleic Acid Analyzer3 refs Ultrasonic Cleaner USC Series, USCM Series, USC0-M Series, USCD Series	I, A IVDR, MDR	EUDAMED record Report an error
Laboratory shakers	W02070401	3D Shaker3 refs Platelet Oscillating Incubator POI Series Shaker SHK Series	A IVDR	EUDAMED record Report an error
Automated 3 part hematology analysers	W0202010201	Auto Hematology Analyzer HEMA-D60313 refs Hematology Analyzer HEMA Series	A IVDR	EUDAMED record Report an error
Biological hoods	W02070301	Biological Safety Cabinet BSC-IIA2-2J3 refs Biological Safety Cabinet IN0084	I, A IVDR, MDR	EUDAMED record Report an error
Blood gas analysers - with classic profile (pH, PO2, PCO2, hct + electrolytes)	W0201040101	Blood Gas Analyzer BGA Series Blood Gas Analyzer BGA-150-3	A IVDR	EUDAMED record Report an error
Centrifuges	W02069003	Centrifuge CFG Series，CFGR Series2 refs Cyto Centrifuge CFG-12D3 refs	A IVDR	EUDAMED record Report an error
Chemistry instruments - other	W02010199	Biochemistry Analyzer Biochemistry Analyzer BA Series2 refs	A IVDR	EUDAMED record Report an error
Erythrocyte sedimentation rate devices	W02029001	ESR Analyzer ESRA Series ESR Analyzer ESRA-10	A IVDR	EUDAMED record Report an error
Gel documentation systems	W020105019002	Fully automatic multifunctional gel imaging system GEP-GD600MF2 refs Gel Imaging System GEP Series	A IVDR	EUDAMED record Report an error
Immunochemistry readers	W0201020201	Microplate Reader3 refs Microplate Reader MPR Series	A IVDR	EUDAMED record Report an error
Ion selective electrolyte analysers	W0201040201	Electrolyte Analyzer EA Series Electrolyte Analyzer EA-7-25-A	A IVDR	EUDAMED record Report an error
Labware dryers	W02079014	Drying Oven/Sterilizing Oven DON Series, DOF Series, DOV Series, DOI Series Forced-Air Drying Oven2 refs	A IVDR	EUDAMED record Report an error
Microtomes	W0202059005	Microtome RMT Series Rotary Microtome RMT-M260	A IVDR	EUDAMED record Report an error
Optical laboratory microscopes	W0202050303	Biological Microscope MSC-5-500MV3 refs Microscope MSC Series	A IVDR	EUDAMED record Report an error
Tissue embedding processors	W0202059004	Embedding coolling plate2 refs Embedding Machine EBD Series	A IVDR	EUDAMED record Report an error
Urinary sediment devices	W0201010202	Fully Automatic Urine Sediment Analyzer Evo-S502 refs Urine Sediment Analyzer UA Series, Evo Series, USA Series	A IVDR	EUDAMED record Report an error
Various electrophoresis instruments - other	W020105019099	Electrophoresis GEP Series Universal Electrophoresis Power Supply	A IVDR	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Nucleic Acid Extraction NAE-01323 refs Nucleic Acid Extractor NAE Series	A IVDR	EUDAMED record Report an error
Automated slide stainers	W0202059002	Slide Stainer TSST Series，IHCS Series	A IVDR	EUDAMED record Report an error
Automated urine analysers	W020101020103	Urine Analyzer UA Series	A IVDR	EUDAMED record Report an error
Carbon dioxide incubators	W02039002	CO2 Incubator ICB Series, EGI Series	A IVDR	EUDAMED record Report an error
DNA thermal cyclers	W02039006	Thermal Cycler PCR Series, PCRTC Series	A IVDR	EUDAMED record Report an error
Electric medical beds - other	V08060199	Electric Operating Table ORB Series	I MDR	EUDAMED record Report an error
Electric medical chairs - other	V08020199	Dental Chair ORB-D1000E3 refs	I MDR	EUDAMED record Report an error
Evaporators	W02079004	Rotary Evaporator REV-2000A	A IVDR	EUDAMED record Report an error
Fume hoods	W02070302	Fume Hood FMH-D4F	I MDR	EUDAMED record Report an error
General coagulation tests - other	W0103020199	Coagulation Analyzer BCA Series, CA Series	A IVDR	EUDAMED record Report an error
Generic use stretchers	V08050101	Aluminum Alloy trolley Stretcher	I MDR	EUDAMED record Report an error
Laboratory refractometers	W02079013	Refractometer RFT-A731	A IVDR	EUDAMED record Report an error
Laboratory titrators	W02079015	Titrator TITR-40C	A IVDR	EUDAMED record Report an error
Laminar airflow hoods	W02070303	Laminar Flow Cabinet LCB-H4F3 refs	I MDR	EUDAMED record Report an error
Melting point devices	W02079011	Melting Point Apparatus MTP-4	A IVDR	EUDAMED record Report an error
Nucleic acid testing apparatuses - rapid and point of care tests	W02050301	Real-time PCR System PCR Series	A IVDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Real-time PCR3 refs	A IVDR	EUDAMED record Report an error
Operating tables	Z12011202	Operating Table ORB-X1N	I MDR	EUDAMED record Report an error
Osmometers	W02079017	Osmometer FPO-2000	A IVDR	EUDAMED record Report an error
PH meters	W02079009	PH Meter BEP-M210-UK	A IVDR	EUDAMED record Report an error
Semi-automated urine analysers	W020101020102	Urine Analyzer UA-SA-200	A IVDR	EUDAMED record Report an error
Serological and dilution pipettes, plastic	W050302010102	Pipette PIPE-MP2 refs	A IVDR	EUDAMED record Report an error
Thermostatic water baths	W02079001	Water Bath WB-S12 refs	A IVDR	EUDAMED record Report an error
Tissue processors	W0202059010	Tissue Processor TSP Series, TSSP Series	A IVDR	EUDAMED record Report an error
Treatment, diagnosis and monitoring medical beds	V080603	Examination tables PTC series，D4 series	I MDR	EUDAMED record Report an error
Various general purpose IVD instruments - other	W02079099	Thermo Sealer TMS Series, SLM Series, TMSC Series, SLM-TII Series	A IVDR	EUDAMED record Report an error
Various processing instruments for hystology / cytology - other	W0202059099	Tissue Flotation Water Bath/Tissue Slide Dryer TSB Series, TSW Series, TSBW Series, TSST Series, THP Series	A IVDR	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	POCT Fully Immunofluorescence Quantitative Analyzer	A IVDR	EUDAMED record Report an error
Venous or arterious blood collection devices - other	W0501010199	Blood Collection Monitor BCM Series	A IVDR	EUDAMED record Report an error
Viscosimeters	W02079016	Viscometer	A IVDR	EUDAMED record Report an error

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