Infitek Co., Ltd.
Registered establishment in Shanghai, China. 49 device types.
Infitek Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Ph Meter and 47 other device types. Its earliest product listing with the FDA dates from 2023.
Registration
| Registered name | INFITEK CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3027645317 |
| FEI number | 3027645317 |
| Establishment type | Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | ROOM 201A, BUILDING 9 (BLOCK B), NO. 2679, HECHUAN ROAD, MINHANG DISTRICT, SHANGHAI,P.C.20 |
| Postal code | 201100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Acid Hematin | Class 2 | Hemoglobin Analysis Meter | 2024 | 3 |
| Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | Class 1 | PCR-Q32-2F, PCR-Q88-1, PCR-Q88-2, PCR-Q32-4F, PCR-Q16-2, PCR-Q16-1B and 9 more | 2024 | 9 |
| Apparatus, Electrophoresis, For Clinical Use | Class 1 | Cellulose Acetate Membrane Electrophoresis, Laminar Flow Cabinet, Sequencing Electrophoresis Tank, Blue Light Integrated Horizontal Electrophoresis Tank, Electrophoresis System, Lab Ventilation Products and 11 more | 2023 | 4 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | Electric suction machine | 2024 | 30 |
| Automated Colony Counter | Class 1 | Molecular Biology Instruments, Colony Counter | 2023 | 3 |
| Automated Urinalysis System | Class 1 | In Vitro Diagnostic Medical Devices, Veterinary Semi-Automatic Urine Analyzer, Semi-Automatic Urine Analyzer, Fully Automatic Urine Analyzer, Urine Analyzer | 2023 | 16 |
| Bath, Incubators/Water, All | Class 1 | Water Bath Oscillator, Thermostatic Magnetic Stirring Bath, Water Bath, Oil Bath, Transparent Water Bath | 2023 | 12 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class 1 | Oil Test Centrifuge, Microplate Centrifuge, PRP Centrifuges, Low Speed Refrigerated Centrifuges, Centrifugal Concentrator, Microhematocrit Centrifuges and 11 more | 2023 | 37 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | Class 1 | Double beam UV Visible Spectrophotometer, Grating Spectrophotometer, Atomic Absorption Spectrophotometer, Spectrophotometer, Flame Photometer, Single beam UV Visible Spectrophotometer and 6 more | 2023 | 13 |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | Class 1 | Pathology Lab Solution, Digital Pathology Slide Scanner | 2023 | 1 |
| Detergent | Class 1 | Cleaning Fluid | 2024 | 5 |
| Device, Blood Mixing And Blood Weighing | Class 1 | Blood Station Equipment, Blood Collection Monitor | 2023 | 3 |
| Device, Gas Generating | Class 1 | Anaerobic Incubators, Molecular Biology Instruments, Anaerobic Jar | 2023 | 3 |
| Device, Vein Location, Liquid Crystal | Class 1 | Medical Device, Vein Finder | 2023 | 10 |
| Diluent, Blood Cell | Class 1 | Hematology reagent Diluent | 2024 | 5 |
| Disinfectant, Medical Devices | Class 1 | Autoclaves & Sterilizers, Medical Ultraviolet Ultrasonic Probe Sterilizer | 2023 | 197 |
| Electrode, Electrocardiograph, Multi-Function | Class 2 | Medical Device, ECG Machine | 2023 | 6 |
| Electrolyte Controls (Assayed And Unassayed) | Class 1 | Electrolyte Analyzer, In Vitro Diagnostic Medical Devices | 2023 | 3 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Mould Incubator, Aerosol Adsorption Air Purifier, Platform Scales, Tablet Hardness Testers, Egg Incubator, Veterinary Hematology Analyzer and 53 more | 2023 | 72 |
| Evacuator, Vapor, Cement Monomer | Class 1 | Water Circulating Vacuum Pump, Diaphragm Vacuum Pump, Vacuum Pumps, Vacuum Pumps & Filtration | 2023 | 3 |
| Evaporator | Class 1 | Evaporation System, Rotary Evaporator, Rotary Evaporator System | 2023 | 4 |
| Exerciser, Non-Measuring | Class 1 | Livifitup Endurance Portable Trainer | 2024 | 82 |
| Filters, Cell Collection, Tissue Processing | Class 1 | Embedding coolling plate, Embedding system, Embedding machine, Pathology Lab Solution, Tissue Embedding System, Embedding heating plate and 1 more | 2023 | 9 |
| Fluorometer | Class 1 | Fluorometer, In Vitro Diagnostic Medical Devices, POCT Testing | 2023 | 8 |
| Gas Chromatograph, Carbon-Monoxide | Class 1 | Gas Chromatograph, Chromatograph | 2023 | 3 |
| Hemocytometer | Class 1 | Blood Cell Counter, Medical Device | 2023 | 8 |
| Instrumentation, High Pressure Liquid Chromatography | Class 1 | Liquid Chromatograph, Chromatograph | 2023 | 3 |
| Investigational Use Only – Hematology | Class N | Hematology reagent Lyse / Hemolysis Agent | 2024 | 1 |
| Light, Microscope | Class 1 | Fluorescence Microscope, Inverted Microscope, Metallurgical Microscope, Stereoscopic Microscope, Biological Microscope, Digital Microscope and 3 more | 2023 | 19 |
| Microtome, Accessories | Class 1 | Vibrating Microtome, Pathology Lab Solution, Microtome, Rotary Microtome | 2023 | 6 |
| Microtome, Cryostat | Class 1 | Fast Freezing Machine, Cryostat Microtome, Microtome, Pathology Lab Solution | 2023 | 8 |
| Mirror, Mouth | Class 1 | Mouth Mirror, ENT&Ophthalmology Diagnostic Equipment | 2023 | 94 |
| Monitor, Patient Position, Light-Beam | Class 1 | Patient Monitor | 2023 | 5 |
| Osmometer For Clinical Use | Class 1 | Freezing Point Osmometer, Medical Device | 2023 | 4 |
| Otoscope | Class 1 | Otoscope, ENT&Ophthalmology Diagnostic Equipment | 2023 | 43 |
| Ph Meter | Class 1 | Benchtop pH Meter, Online PH Meter, pH Meters, Electrochemistry & Titration, Portable pH Meter | 2023 | 3 |
| Plasma, Coagulation Control | Class 2 | Semi-auto Coagulation Analyzer, Fully Automatic Coagulation Analyzer, Coagulation Analyzer, In Vitro Diagnostic Medical Devices | 2023 | 3 |
| Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | Class 1 | Ultra-pure Water Purifier, Water Purification, Water Distiller, Water Purifier | 2023 | 14 |
| Real Time Nucleic Acid Amplification System | Class 2 | PCR-H88-1, PCR-H88-2, lsothermal Amplification System, Molecular Biology Instruments, FD-CT-1600, PCR-H16-1 and 2 more | 2023 | 15 |
| Refrigerator, Freezer, Blood Storage | Class 2 | Portable Refrigerator, Chest Freezer, Refrigerator & Freezer, Solar Medicine Refrigerator, Cryogenic Freezer, Corpse Refrigerator and 6 more | 2023 | 9 |
| Regulator, Temperature | Class 1 | Rotary Evaporator System, Dynamic Temperature Control System, Vacuum Controller, Evaporation System, Low-temperature constant temperature bath, Refrigerated and Heating Circulator and 4 more | 2023 | 3 |
| Shaker/Stirrer | Class 1 | Mixer, Shakers, Combination Stirring Hotplates, Orbital Shaker, Hotplates & Stirrers, Rocking Shaker and 10 more | 2023 | 13 |
| Sieves, Tissue | Class 1 | Sample Pre-Treatment Products, Sieve Shaker | 2023 | 3 |
| Slide Stainer, Automated | Class 1 | Pathology Lab Solution, Slide Stainer | 2023 | 14 |
| Thermocycler, Generic | Class 1 | PCRTC-32, PCR-TC2, PCR-96AF, PCR-9612E, PCR-96S, PCR-4T and 21 more | 2024 | 5 |
| Tube, Collection, Capillary Blood | Class 1 | Medical Device, Blood Collection Tube, PRP Tube, Medical Consumables | 2023 | 16 |
| Unit, Drying | Class 1 | Automatic Thermostatic X-Ray Film Dryer, Forced-Air Drying Oven, Dual Convection Oven, Vacuum Oven, Drying Oven, High Temperature Oven and 3 more | 2023 | 6 |
| Unit, Filter, Membrane | Class 1 | Filter Funnel Manifolds, Vacuum Pumps & Filtration | 2023 | 17 |
| Washer Of Body Waste Receptacles | Class 1 | Vertical Emergency Eye Washer, Lab & Medical Furniture, Portable Eye Washer, Removable Eye Washer, Combination Shower & Eye Washer, Wall Mounted Shower and Eye Washer and 2 more | 2023 | 11 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | Chromatographs, Spectrophotometers, Medical analyzers, Life science instruments |
| Certifications | ISO 9001, ISO 13485, CE, FDA approved |
| Export markets | 176 countries |
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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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