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HANAROSTENT® Esophagus Asymmetric (CCC)
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref ECN18090-X070Model HANAROSTENT® Esophagus Asymmetric (CCC)
Identity
- Trade Name
- HANAROSTENT® EUDAMEDHANAROSTENT® Esophagus Asymmetric (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
- ECN18090-X070 EUDAMEDFDA UDIHANAROSTENT® Esophagus Asymmetric (CCC) EUDAMED
- Description
- Full Covered metallic esophagus stent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806367020352 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08806367020352 EUDAMED
- 510(k) Number
- K213251 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® Esophagus Asymmetric (CCC) by M.I.Tech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K213251 also covers:
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
- HANAROSTENT® Esophagus Asymmetric (CCC) — M.I.Tech Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- M.I.Tech Co., Ltd.
Sources (2)
- FDA UDI b213ddcd-3c0d-48f5-b567-17c7bbdb44b4 37 fields · synced Oct 6, 2026
- EUDAMED 2a82cc03-f7bf-4d10-ad60-4c8e9a7e28d7 61 fields · synced Jul 18, 2026