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Hanarostent®
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref TCS-16-020-050Model HANAROSTENT® Trachea/Bronchium (CCC)
Identity
- Trade Name
- HANAROSTENT® EUDAMEDHANAROSTENT® Trachea/Bronchium(CCC) FDA UDI
- Generic Name
- Polymer-metal tracheal/bronchial stent FDA UDI
- Device Name
- Trachea/Bronchium Stent with Delivery System EUDAMEDFull Covered metallic tracheal stent FDA UDI
- Model / Reference
- HANAROSTENT® Trachea/Bronchium (CCC) EUDAMEDTCS-16-020-050 EUDAMEDFDA UDI
- Description
- Full Covered metallic tracheal stent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806367079749 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08806367079749 EUDAMED
- 510(k) Number
- K201342 FDA UDI
- FDA Product Code
- JCT FDA UDI
- EMDN Code
- P0401 TRACHEOBRONCHIAL PROSTHESES EUDAMED
- GMDN Term
- Polymer-metal tracheal/bronchial stent FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3720 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Stent Diameter — 16 Millimeter FDA UDIStent Length — 20 Millimeter FDA UDI
Hanarostent® by M.I.Tech Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201342 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08806367079749 | 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 (3)
- EUDAMED 85a460aa-ec77-4dc4-97fe-3a3c194e31dd 61 fields · synced Aug 3, 2026
- FDA UDI 178de4db-cbaa-4deb-91ed-c1c91e7d676a 37 fields · synced May 30, 2026
- FDA 510(k) K201342 1 fields · synced May 18, 2026