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Quality

Made to be imported with confidence.

Every lot is produced in our own cleanroom with documented quality control, as a licensed Korean medical device manufacturer. A safe lens is the foundation of a brand that lasts.

Quality basis

What our quality rests on

The foundations behind every lot. Supporting documentation is provided on request or to registered buyers.

KGMP
GMP quality system
Cert. no. KCL-AAB-3191
ISO
ISO 13485
Medical device QMS
CE
CE marked
European conformity
MFDS
Medical device
Korea MFDS licensed maker
KR
Made in Korea
Domestic production
QC
In-house QC
Per-lot inspection

Certificate copies (KGMP, ISO 13485, CE) are provided on request or to registered buyers.

Quality control

How we hold the line

01

Cleanroom production

Controlled environment manufacturing to limit particulate and contamination.

02

Material control

MPC-H material and water content verified before and during production.

03

Dimensional check

Base curve, diameter and power measured against specification.

04

Optical & visual

Surface, edge and color inspection for defects before packaging.

05

Sterilization & seal

Solution, sterilization and seal integrity checks per lot.

06

Records & traceability

Lot-level records so any batch can be traced and documented.

Safety

Biocompatible by design.

MPC-H shares the phosphorylcholine structure of the human cell membrane. Combined with our QC, that material choice is what lets wearers use the lens comfortably and lets brands stand behind it.

  • Biocompatible material as the safety baseline
  • Documented QC at material, dimension and optical stages
  • Regulatory files prepared per destination market
Cleanroom production line Inspection and measurement instruments Polymerization equipment Production workstation

Production and inspection equipment, Chilgok plant.

Need our specifications?

Registered buyers can download spec sheets and material data. Or request them with your inquiry.