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Hanarostent®
EUDAMEDClass IIb (EU MDR)
Ref SHC-08-120-060Model HANAROSTENT® Biliary (CCC)
Identity
- Trade Name
- HANAROSTENT® EUDAMED
- Device Name
- Biliary Stent with Delivery System EUDAMED
- Model / Reference
- HANAROSTENT® Biliary (CCC) EUDAMEDSHC-08-120-060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806367016836 EUDAMED
- Basic UDI-DI
- B-08806367016836 EUDAMED
- EMDN Code
- P0502 BILIARY AND PANCREATIC PROSTHESES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hanarostent® by M.I.Tech Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08806367016836 | Class IIb | Active |
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Manufacturer
- Manufacturer
- M.I.Tech Co., Ltd
- EUDAMED SRN
- KR-MF-000011623
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 6f87adf3-5666-479d-8d97-5f4cbcfa7fbe 61 fields · synced May 23, 2026