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Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

Hibarry

UDI-DI 08809369092822Basic UDI-DI 880936909BNC003HC

Class III · MDR · BNC KOREA, Inc.

Identification
Model
1.5, 3, 5 ml
EMDN
M0406
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2023-MDR/TD-004/C

EU technical documentation assessment · valid

Notified body: 3EC International a.s. (2265)

Valid from 2025-11-11 · Expiry 2028-01-09

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

2023-MDR/QS-004/C

EU quality management system · valid

Notified body: 3EC International a.s. (2265)

Valid from 2025-11-11 · Expiry 2028-01-09

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

BNC KOREA, Inc.

SRN KR-MF-000008321

KR · Dalseo-gu, Daegu

manufacturer

Authorised representative: Javitech Consulting GmbH (DE-AR-000045915)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hibarry-2822 · UDI page: /udi/08809369092822

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