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.
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㎖
- Residual Monomer ≒ 0
- In vitro excretion
- Stable Viscoelasticity
- Various Indications(Face, Body)
- Synthetic ease with other substances
- High potential as a DDa
for Medical Device
Certificate of Free Sales
Philippines FDA(CPR ongoing)