Segmented Esophageal Stent System

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name: Segmented Esophageal Stent System FDA UDI
Generic Name: Polymer-metal oesophageal stent FDA UDI
Device Name: Double cup 18×60,fully covered stent with 6.7mm outer sheath,650mm working length delivery system FDA UDI
Model / Reference: NST61-224-18.060 FDA UDI
Description: Double cup 18×60,fully covered stent with 6.7mm outer sheath,650mm working length delivery system FDA UDI

Identifiers

Primary DI / UDI-DI: 06932503580519 FDA UDI
510(k) Number: K182910 FDA UDI
FDA Product Code: ESW FDA UDI
GMDN Term: Polymer-metal oesophageal stent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.3610 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Stent Diameter — 18 Millimeter FDA UDI
Stent Length — 60 Millimeter FDA UDI

Category: Polymer-metal oesophageal stent

Segmented Esophageal Stent System by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymer-metal oesophageal stent.

Esophageal TTS Stent — Taewoong Medical · Class II
Esophageal TTS Stent — Taewoong Medical · Class II
HANAROSTENT® Esophagus TTS(NCN) — M.I.Tech Co., Ltd. · Class II
Esophageal TTS Stent — Taewoong Medical · Class II
Esophageal TTS Stent — Taewoong Medical · Class II
Esophageal TTS Stent — Taewoong Medical · Class II
HANAROSTENT® Esophagus TTS(CCC) — M.I.Tech Co., Ltd. · Class II
HANAROSTENT® Esophagus (NCN) — M.I.Tech Co., Ltd. · Class II

Cleared under the same submission

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: Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

FDA UDI 58deef55-6566-40e6-89a2-23b915d8eab6 36 fields · synced May 30, 2026