META BIOMED CO., LTD.

Certificate HZ 2020208-1

Rev. Rev.2Amended

Valid until: Aug 23, 2027

Certificate HZ 2020208-1 is a valid Quality management system issued to META BIOMED CO., LTD. and registered in EUDAMED. Valid until August 23, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2020208-1
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2020208-1Rev.2

Validity

Issued: Jul 1, 2025
Valid from: Jul 1, 2025
Valid until: Aug 23, 2027

Manufacturer

Manufacturer: META BIOMED CO., LTD.
Manufacturer SRN: KR-MF-000009681
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

Amended

Supersedes

HZ 2020208-1Quality management systemIssuedJun 3, 2024 → Aug 23, 2027

Scope coverage

Class I1Class IIb1

2 scopes

Product of Class I, reusable surgical instruments: H030101 - MULTIPLE CLIP APPLIERS FOR OPEN SURGERY H030201 - MULTIPLE CLIP APPLIERS FOR VIDEOSURGERY The scope of certification is limited to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.
Class I
Product of Class IIb: H030102 - HAEMOSTASIS CLIPS FOR OPEN SURGERY SINGULAR CLIPS FOR OPEN SURGERY NON-ABSORBABLE SINGULAR CLIPS FOR OPEN SURGERY H030299 - HAEMOSTASIS CLIPS FOR VIDEOSURGERY HAEMOSTASIS CLIPS FOR VIDEOSURGERY – OTHER
Class IIb

Documents

LanguagesEN