BNC KOREA, Inc.

Certificate 2026-AXVI/QS-002

Rev. 00Issued

Valid until: Jan 9, 2028

Certificate 2026-AXVI/QS-002 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: 2026-AXVI/QS-002
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652026-AXVI/QS-00200

Validity

Issued: Mar 6, 2026
Valid from: Mar 6, 2026
Valid until: Jan 9, 2028

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: Yes
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: Yes
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III2

2 scopes

RESORBABLE FILLING AND RECONSTRUCTION DEVICES
Class III
DEVICE
Class III

Documents

LanguagesEN