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  • MD Atlas
  • Documents

BNC KOREA, Inc.

Certificate 2023-MDR/TD-004/C

Rev. 03Issued
Valid until
Jan 9, 2028

Certificate 2023-MDR/TD-004/C is a valid Technical documentation 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/TD-004/C
Certificate type
Technical documentation
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
22652023-MDR/TD-004/C03

Validity

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

Notified body

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

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified1

1 scope

  • Anti-Adhesion Barrier Gel
    880936909BNC003HC

Documents

LanguagesEN

Manufacturer

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

Covered devices

  • Anti-Adhesion Barrier GelClass III
    880936909BNC003HC

Linked SSCPs

  • SSCP BNC-SSCP-02