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Hanarostent®
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref CNJF-25-120-230Model HANAROSTENT® LowAx™ Colon/Rectum (NNN)
Identity
- Trade Name
- HANAROSTENT® EUDAMEDHANAROSTENT® LowAxTM Colon/Rectum(NNN) FDA UDI
- Generic Name
- Bare-metal colonic stent FDA UDI
- Device Name
- Colon/Rectum Stent with Delivery System EUDAMEDUn-covered self-expanding nitinol colon stent FDA UDI
- Model / Reference
- HANAROSTENT® LowAx™ Colon/Rectum (NNN) EUDAMEDCNJF-25-120-230 EUDAMEDFDA UDI
- Description
- Un-covered self-expanding nitinol colon stent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806367080929 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08806367080929 EUDAMED
- 510(k) Number
- K190141 FDA UDI
- FDA Product Code
- MQR FDA UDI
- EMDN Code
- P0503 COLONIC AND DUODENAL PROSTHESES EUDAMED
- GMDN Term
- Bare-metal colonic 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 — 25 Millimeter FDA UDIStent Length — 120 Millimeter FDA UDILength — 2300 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-08806367080929 | 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 d502a85c-71f3-4968-acda-1bb0834f376a 61 fields · synced Jun 1, 2026
- FDA UDI 52bd50f1-4d5d-455c-bcd5-72af1e12985f 37 fields · synced May 30, 2026