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Manufacturing

Manufacturing

Highly Regulated GMP Level

ISO 13485:2016 and Korean GMP(in progress)recognized in terms of strict safety regulations.

  • Required Validations (PV, MV, CV, CSV, Sterilization, Shipping)
  • Constant Post Marketing Surveillance to Ensure Product Safety

MI-LINKER has passed all the required ISO13485:2016 to manufacture the filler (injection; medical device – class Ⅲ)

And Korean GMP is in progress with the goal of approval in the second half of 2021.

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New Generation Polymer Filler

This is absorbent mid-term filler that maintains optimal viscoelasticity and increases safety by extremely removing harmful unreacted monomers(<0.1ppm)that inevitable occur during manufacturing.

  • Hydrophilic Hydrogel
  • 3.75% Polyacrylamide & 96.25% Sodium Chloride Solution
  • Slowly absorbed by macrophages and excreted in urine
  • Light material as like pure water
  • 3D Matrix Structure
  • Line-up: 1㎖, 10㎖
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  • safety_icon
    Safety
    • Residual Monomer ≒ 0
    • In vitro excretion
    • Hydrophilic
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    Efficacy
    • Stable Viscoelasticity
    • Biocompatibility
    • Long-duration
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    Expandability
    • Various Indications(Face, Body)
    • Synthetic ease with other substances
    • High potential as a DDa

Certifications

  • certifications_01
    ISO13485:2016 Certified
    for Medical Device
  • certifications_02
    Certificate of Free Sales
    by KFDA
  • certifications_03
    Patent Registration
  • certifications_04
    Product/Completed Operations
    Liability($100,000)
  • certifications_05
    Philippines FDA(CPR ongoing)
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