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HANAROSTENT® LowAxTM Colon/Rectum(NNN)

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref CNJF-22-120-230Model HANAROSTENT® LowAx™ Colon/Rectum (NNN)

by M.I.Tech Co., Ltd.

Identity

Trade Name
HANAROSTENT® EUDAMED
HANAROSTENT® LowAxTM Colon/Rectum(NNN) FDA UDI
Generic Name
Bare-metal colonic stent FDA UDI
Device Name
Colon/Rectum Stent with Delivery System EUDAMED
Un-covered self-expanding nitinol colon stent FDA UDI
Model / Reference
CNJF-22-120-230 EUDAMEDFDA UDI
HANAROSTENT® LowAx™ Colon/Rectum (NNN) EUDAMED
Description
Un-covered self-expanding nitinol colon stent FDA UDI

Identifiers

Primary DI / UDI-DI
08806367080783 EUDAMEDFDA UDI
Basic UDI-DI
B-08806367080783 EUDAMED
510(k) Number
K183616 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 EUDAMED
Class 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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 2300 Millimeter FDA UDI
Stent Length — 120 Millimeter FDA UDI
Stent Diameter — 22 Millimeter FDA UDI

HANAROSTENT® LowAxTM Colon/Rectum(NNN) by M.I.Tech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K183616 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
M.I.Tech Co., Ltd.

Sources (2)

  • FDA UDI 5b935d30-7f8d-4bb7-8389-731481683578 37 fields · synced Oct 6, 2026
  • EUDAMED 920641ec-2667-403e-9138-59e88e843d51 61 fields · synced Jul 13, 2026