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Hibarry

by BNC KOREA, Inc. 2 variants

Ref HB2Model 1.5, 3, 5 ml

Hibarry (HB2) is a medical device (EU MDR Class III; EMDN category dressings for the prevention of post-operative adhesions) made by BNC KOREA, Inc., registered in EUDAMED on 15 Nov 2024 (Basic UDI-DI 880936909BNC003HC) with CE/MDR certificate 2023-MDR/QS-004/D valid until 9 Jan 2028, active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

9 Jan 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2023-MDR/QS-004/D Date6 Oct 2026IssuedStatusActive expires 9 Jan 2028

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2023-MDR/QS-004/D Active Amended

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    6 Oct 2026
    Expires
    9 Jan 2028
    Reason
    Mnf data change
  • 2023-MDR/TD-004/D Active Amended

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    6 Oct 2026
    Expires
    9 Jan 2028
    Reason
    Mnf data change

Timeline

5 dated events

  1. Registered EUDAMED 880936909BNC003HC
  2. Certificate issued EUDAMED 2023-MDR/QS-004/D
  3. Certificate issued EUDAMED 2023-MDR/TD-004/D
  4. Certificate expires EUDAMED 2023-MDR/QS-004/D
  5. Certificate expires EUDAMED 2023-MDR/TD-004/D

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Anti-Adhesion Barrier Gel
Model / reference
1.5, 3, 5 ml, HB2
Primary DI / UDI-DI
08809369092822
Basic UDI-DI
880936909BNC003HC
Direct marketing DI
08809369092822
EMDN code
M0406 Dressings for the prevention of post-operative adhesions
Device class
Class III
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000008321
Authorised representative
Javitech Consulting GmbH DE-AR-000045915

Similar devices in this category

Other devices filed under DRESSINGS FOR THE PREVENTION OF POST-OPERATIVE ADHESIONS.

Other devices from BNC KOREA, Inc.

See all devices from BNC KOREA, Inc. →

Properties

  • Supplied sterile
  • Implantable
Other properties (12, all answered No)