Scitek Global Co., Ltd.
Registered establishment in Jinan, Shandong, China. 43 device types.
Scitek Global Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Ph Meter and 41 other device types. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | SCITEK GLOBAL CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3043088937 |
| FEI number | 3043088937 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Jinan |
|---|---|
| Province | Shandong |
| Address | Room 5, Building 5, Jinan Biomedical Zone, No. 30766 Jingshi East Road, Jinan, Shandong |
| Postal code | 250000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Acid Hematin | Class 2 | Hemoglobin Analysis Meter | 2025 | 3 |
| Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | Class 1 | Real-time Fluorescence Quantitative PCR Detection System | 2025 | 9 |
| Apparatus, Electrophoresis, For Clinical Use | Class 1 | Automatic Gel Imaging and Analysis System, Electrophoresis Cell, Inner Core of Electrophoresis Tank, Vertical Electrophoresis Tank, Automatic Chemiluminescence Gel Imaging System, Horizontal Electrophoresis Tank and 4 more | 2025 | 4 |
| Automated Colony Counter | Class 1 | Colony Counter, Molecular Biology Instrument | 2025 | 3 |
| Automated Urinalysis System | Class 1 | Fully Automatic Urinalysis Analyzer, Urine Analyzer, Semi-Automatic Urinalysis Analyzer | 2025 | 16 |
| Bath, Incubators/Water, All | Class 1 | Thermostatic Shaking Water Bath, High Precision Low-Temperature Thermostatic Bath, Thermostatic Water Bath, Thermostatic Magnetic Stirring Bath, Thermostatic Water Tank, Transparent Water Bath | 2025 | 12 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class 1 | Cell Washer/Serofuge Centrifuge, Cyto Centrifuge, Low Speed Centrifuge, High Speed Mini Centrifuge, Benchtop Low Speed High Capacity Centrifuge, Benchtop High Speed Micro Refrigerated Centrifuge and 16 more | 2025 | 37 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | Class 1 | Micro-Volume UV/VIS Spectrophotometer, Spectrophotometer, Automatic Refractometer, Flame Photometer, Scanning Spectrophotometer, Refractometers and 14 more | 2025 | 13 |
| Device, Automated Sedimentation Rate | Class 1 | ESR Analyzer | 2025 | 4 |
| Device, Blood Mixing And Blood Weighing | Class 1 | Blood Plasma Extractor, Blood Collection Monitor | 2025 | 3 |
| Device, Gas Generating | Class 1 | Anaerobic Incubator, Anaerobic Jar | 2025 | 3 |
| Device, Vein Location, Liquid Crystal | Class 1 | Vein Finder | 2025 | 10 |
| Diluent, Blood Cell | Class 1 | Hematology reagent Diluent | 2025 | 5 |
| Electrode, Electrocardiograph, Multi-Function | Class 2 | ECG Machine | 2025 | 6 |
| Electrode, Ion Selective (Non-Specified) | Class 1 | Electrolyte Analyzer | 2025 | 4 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Climate Incubator, Vertical Laminar Flow Cabinet, Microplate Washer, Halogen Moisture Analyzer, Snowflake Ice Maker, Dissolution Tester and 54 more | 2025 | 72 |
| Evacuator, Vapor, Cement Monomer | Class 1 | Manifolds Vacuum Filtration, Chemical Resistant Vacuum Pump, Diaphragm Vacuum Pump, Water Circulating Vacuum Pump, Oil-free Vacuum Suction Filter Pump, Rotary Slice Vacuum Pump | 2025 | 3 |
| Evaporator | Class 1 | Low Temperature Circulator, Refrigerated and Heating Circulator, Dynamic Temperature Control System, Vacuum Controller, Low temperature cooling liquid circulator, Cooling Circulator and 1 more | 2025 | 4 |
| Exerciser, Non-Measuring | Class 1 | Livifitup Endurance Portable Trainer | 2025 | 82 |
| Fluorometer | Class 1 | Fluorometer | 2025 | 8 |
| Gas Chromatograph, Carbon-Monoxide | Class 1 | Gas Chromatograph | 2025 | 3 |
| Hemocytometer | Class 1 | Blood Cell Counter | 2025 | 8 |
| Instrumentation, High Pressure Liquid Chromatography | Class 1 | Liquid Chromatograph | 2025 | 3 |
| Light, Microscope | Class 1 | LCD Digital Microscope, Inverted Microscope, Polarizing Micrscope, Stereoscopic Microscope, Biological Microscope, Reading microscope and 5 more | 2025 | 19 |
| Mass Spectrometer, Clinical Use | Class 1 | Titrator, Salinity Meters, COD Analyzer, ORP Meters, Benchtop PH Meter, Water Hardness Meters and 7 more | 2025 | 2 |
| Microtome, Accessories | Class 1 | Slide Cabinet, Tissue Processor, Paraffin Trimmer, Digital Pathology Slide Scanner, Slide Dryer, Tissue Flotation Water Bath and 1 more | 2025 | 6 |
| Microtome, Cryostat | Class 1 | Semi-Automated Rotary Microtome, Manual Rotary Microtome, Vibrating Microtome, Cryostat Microtome, Floatation Workstation, Fully Automatic Microtome and 2 more | 2025 | 8 |
| Mirror, Mouth | Class 1 | Mouth Mirror | 2025 | 94 |
| Monitor, Patient Position, Light-Beam | Class 1 | Patient Monitor | 2025 | 5 |
| Osmometer For Clinical Use | Class 1 | Freezing Point Osmometer | 2025 | 4 |
| Otoscope | Class 1 | Otoscope | 2025 | 43 |
| Ph Meter | Class 1 | Online pH Meter, Bluetooth Pocket pH/Conductivity Meter, Benchtop pH/Ion Meter, Pocket pH Tester, PH Electrode, Electrochemistry & Titration and 3 more | 2025 | 3 |
| Plasma, Coagulation Control | Class 2 | Coagulation Analyzer, Semi-auto Coagulation Analyzer, Auto Coagulation Analyzer | 2025 | 3 |
| Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | Class 1 | Ultra Water Purifier(Low TOC), Ultra Water Purifier(Physicochemical), High Pure Water Purifier, Ultra Water Purifier(Eliminating endotoxin), Ultra Water Purifier(Synthesizing), Water Purifier and 1 more | 2025 | 14 |
| Real Time Nucleic Acid Amplification System | Class 2 | Molecular Biology Instruments, lsothermal Amplification System | 2026 | 15 |
| Refrigerator, Freezer, Blood Storage | Class 2 | Tuna Freezer, Single Door Laboratory Refrigerator, Blood Bank Refrigerator, Portable Ultra-low Temperature Freezer, Solar Refrigerator, Ultra Low Temperature Freezer and 8 more | 2025 | 9 |
| Regulator, Temperature | Class 1 | Rotary Evaporator System, Evaporation System, Vacuum Controller, Low Temperature Circulator, Medical Temperature Controller Device, Thermostatic baths and circulators and 4 more | 2026 | 3 |
| Shaker/Stirrer | Class 1 | Double-layer Shaker, Multi-position Magnetic Stirrer, Vortex Mixer, Rocking Rotator, Single-layer Shaker, Orbital Shaker and 24 more | 2025 | 13 |
| Sieves, Tissue | Class 1 | Sieve Shaker | 2025 | 3 |
| Slide Stainer, Automated | Class 1 | Slide Stainer, Pathology Lab Solution | 2025 | 14 |
| Tube, Collection, Capillary Blood | Class 1 | Blood Collection Tube, Medical Consumables, PRP Tube | 2025 | 16 |
| Unit, Drying | Class 1 | Benchtop Constant-Temperature Drying Oven, Infrared Fast Heating Drying Oven, Drying Oven/Incubator(Dual-use), Vacuum Oven, Constant Temperature Drying Oven, Horizontal Drying Oven(Natural Convection) and 2 more | 2025 | 6 |
| Washer Of Body Waste Receptacles | Class 1 | Eye Washer, Portable Emergency Eye Wash, Combined Emergency Shower&Eye Wash, Wall-mounted Shower&Eye Wash, Floor-mounted Emergency Eye Wash, Benchtop/Hand-held Eye Wash | 2025 | 11 |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Biological safety cabinets, Laminar flow cabinets, Fume hoods, Ultra-low temperature freezers, Autoclaves |
|---|---|
| Certifications | ISO 9001, ISO 13485, ISO 45001, ISO 14001, ETL, CE, FDA |
| Export markets | Global distribution network |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | 70 |
| Labpeak Co., Ltd. | 43 |
| Jinan Babio Biotechnology Co., Ltd. | 25 |
| Shandong Lianfa Medical Plastic Products Co., Ltd. | 3 |
| Shandong Corecare Technology Limited | 2 |
| Dragon Crown Medical Co., Ltd. | 2 |
| Shandong Lening Medical Technology Co., Ltd. | 1 |
| Onehalf Design Co., Ltd. | 1 |
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.
The manufacturer named here can complete this record.