BNC KOREA, Inc.

Certificate 2023-MDR/QS-004/C

Rev. 03Issued

Valid until: Jan 9, 2028

Certificate 2023-MDR/QS-004/C is a valid Quality management system issued to BNC KOREA, Inc. and registered in EUDAMED. Valid until January 9, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 2023-MDR/QS-004/C
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652023-MDR/QS-004/C03

Validity

Issued: Nov 11, 2025
Valid from: Nov 11, 2025
Valid until: Jan 9, 2028

Manufacturer

Manufacturer: BNC KOREA, Inc.
Manufacturer SRN: KR-MF-000008321
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

Anti-Adhesion Barrier GelClass III
880936909BNC003HC

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III2

2 scopes

Anti-Adhesion Barrier Gel
Class III
DEVICE
Class III

Documents

LanguagesEN