Our Experience
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Drug PMF
  DMF/API registration
  Generic Drug Registration
Ophthalmic Devices: Contact Lens FDA 510K/TFDA registration,
  Contact Lens clinical study
  Ophthalmic Endoscope
Cardiovascular Device: Drug Eluting Stent
  Diagnostic Catheter / Guiding Catheter
  Blood Pressure Monitor system, central aortic systolic pressure monitor
Dental Devices: Porcelain powder for clinical use
  dental implant system including abutment..
Anesthesiology Devices:  CPAP/Humidifier
Immunology and Microbiology devices:  Gastrointestinal pathogen, Respiratory Virus panel PCR kits, fecal calprotectin ELISA, Rapid Test_ SARS-CoV-2(COVID-19) Neutralizing Ab Test
General and Plastic Surgery Devices: Ultrasound, Laser, RF, Picocare Laser ….
Obstetrics and gynecology Devices: Abortion Cannula, Trocar…
Orthopedic Devices: Pedicle screw, cage, spinal fixation…
Physical medicine Devices power muscle stimulator
Neurology Devices EEG, EMG, ECG, High Intensity focuse ultrasound for essential tremor (HIFU)
Gastroenterology and Urology Devices  
General Hospital and Personal Use Devices Face Mask, Glucosemeter, Sterilizing container system
Radiology Devices  
Clinical Chemistry and Clinical Toxicology Devices  
Hematology and Pathology Devices ADAMTS-13 activity ELISA KIT
Ear, Nose, and Throat Devices