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Hanarostent®
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ECBA-18-090-230Model HANAROSTENT® Esophagus TTS (CCC)
Identity
- Trade Name
- HANAROSTENT® EUDAMEDHANAROSTENT® Esophagus TTS(CCC) FDA UDI
- Generic Name
- Polymer-metal oesophageal stent FDA UDI
- Device Name
- Esophageal Stent with Delivery System EUDAMEDFull Covered metallic esophagus stent FDA UDI
- Model / Reference
- HANAROSTENT® Esophagus TTS (CCC) EUDAMEDECBA-18-090-230 EUDAMEDFDA UDI
- Description
- Full Covered metallic esophagus stent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806367066312 EUDAMED08806367088277 FDA UDI
- Basic UDI-DI
- B-08806367066312 EUDAMED
- 510(k) Number
- K200860 FDA UDI
- FDA Product Code
- ESW FDA UDI
- EMDN Code
- P050199 ESOPHAGEAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Polymer-metal oesophageal stent FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3610 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 — 18 Millimeter FDA UDIStent Length — 90 Millimeter FDA UDI
Hanarostent® by M.I.Tech Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08806367066312 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 (2)
- EUDAMED a89be601-5f0b-4e1b-9f99-78ff89c7da46 61 fields · synced May 31, 2026
- FDA UDI 5233ebb2-5a04-4554-908c-00a8fa2bb2f0 37 fields · synced May 30, 2026