Identity
- Trade Name
- Hibarry EUDAMED
- Device Name
- Anti-Adhesion Barrier Gel EUDAMED
- Model / Reference
- 1.5, 3, 5 ml EUDAMEDHB2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809369092822 EUDAMED
- Basic UDI-DI
- 880936909BNC003HC EUDAMED
- Direct Marketing DI
- 08809369092822 EUDAMED
- EMDN Code
- M0406 DRESSINGS FOR THE PREVENTION OF POST-OPERATIVE ADHESIONS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hibarry by BNC KOREA, Inc. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880936909BNC003HC | Class III | Active |
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Manufacturer
- Manufacturer
- BNC KOREA, Inc.
- EUDAMED SRN
- KR-MF-000008321
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (1)
- EUDAMED 99595572-c915-45ee-9d01-020e823fbfc2 61 fields · synced Jun 18, 2026