Medios Co., Ltd.

Certificate KR23/00000139

Rev. 2Supplemented

Valid until: Aug 31, 2028

Certificate KR23/00000139 is a valid Quality management system issued to Medios Co., Ltd. and registered in EUDAMED. Valid until August 31, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: KR23/00000139
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1639KR23/000001392

Validity

Issued: Jan 9, 2025
Valid from: Jan 9, 2025
Valid until: Aug 31, 2028

Manufacturer

Manufacturer: Medios Co., Ltd.
Manufacturer SRN: KR-MF-000011624
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

KR23/00000139Quality management systemIssuedAug 31, 2023 → Aug 31, 2028

Scope coverage

Class IIa3

3 scopes

MDN1206, MDS1005, MDS1012
Class IIa
Sterile Soft Contact Lens (Model: Cube-I 38)
Class IIa
Sterile Soft non corrective Colored Contact Lens (Model: Hi-Color 58)
Class IIa

Documents

LanguagesEN