Our Experience
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Dru   PMF applifaction in compalince with PIC/S GMP/Generic Drug filing
    DMF/API application
Quality System   ISO 13485/TFDA QMS/MDR QMS
    MDSAP _US_Brazil
MDR 2017/745 Technical Documentation/CER Acupuncture Needle
    Face Mask
    Anti-Decubitus Air Mattress

Medical Device

  Ophthalmic Devices: Contact Lens FDA 510K/TFDA registration,
    Contact Lens clinical study
    Direct Ophthalmoscope/Indirect Ophthalmoscope
    Ophthalmic Endoscope
  Cardiovascular Device: Drug Eluting Stent
    PTCA / CTO
    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 instrument….
  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