Huvitz Co., Ltd.

Certificate HZ 2020221-1

Rev. Rev.1Supplemented

Valid until: Sep 11, 2029

Certificate HZ 2020221-1 is a valid Quality management system issued to Huvitz Co., Ltd. and registered in EUDAMED. Valid until September 11, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2020221-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2020221-1Rev.1

Validity

Issued: Feb 14, 2025
Valid from: Feb 14, 2025
Valid until: Sep 11, 2029

Manufacturer

Manufacturer: Huvitz Co., Ltd.
Manufacturer SRN: KR-MF-000015802
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
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

HZ 2020221-1Quality management systemIssuedSep 12, 2024 → Sep 11, 2029

Scope coverage

Class I1Class IIa1

2 scopes

Z121201 - OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS
Class I
Z121201 - OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS
Class IIa

Documents

LanguagesEN