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.

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㎖

Safety
- Residual Monomer ≒ 0
- In vitro excretion
- Ｈydrophilic
Efficacy
- Stable Viscoelasticity
- Biocompatibility
- Long-duration
Expandability
- Various Indications(Face, Body)
- Synthetic ease with other substances
- High potential as a DDa

Certifications

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