Consulting Wallah › Device Explorer › Cardiovascular › Polymer-metal oesophageal stent
Device Explorer · FDA GUDID · GMDN 61751

Polymer-metal oesophageal stent

A non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other l

US‑registered devices1,006in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile93%labelled sterile
Prescription97%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Bcm Co., Ltd.46446%
M.I.Tech Co., Ltd.19619%
Taewoongmedical.Co.,Ltd17317%
Merit Medical Systems, Inc.667%
Micro-Tech (Nanjing) Co., Ltd.515%
Boston Scientific Corporation343%
Sewoon Medical Co., Ltd.121%
Cook Ireland Ltd101%

Top labelers

CompanyDevicesShare
Bcm Co., Ltd.46446%
M.I.Tech Co., Ltd.19619%
Taewoongmedical.Co.,Ltd17317%
Merit Medical Systems, Inc.667%
Micro-Tech (Nanjing) Co., Ltd.515%
Boston Scientific Corporation343%
Sewoon Medical Co., Ltd.121%
Cook Ireland Ltd101%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Segmented Esophageal Stent SystemEsophageal Stent SystemALIMAXX-ES™EndoMAXX®RESILIENCE™Agile™ EsophagealAgile™ EsophagealEvolutionHANAROSTENT® Esophagus Upper (CCC)Esophageal TTS StentHILZO Esophageal stentsNiti-S Esophageal StentBONASTENT® EsophagealHANAROSTENT® Esophagus Asymmetric (CCC)HANAROSTENT® Esophagus (NCN)HANAROSTENT® Esophagus (CCC)

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
ESWProsthesis, Esophageal977
ESWPROSTHESIS, ESOPHAGEAL114

GMDN & GCC registration

  • GMDN code 61751 · implantable
  • Single‑use 100% · sterile 93% · Rx‑only 97% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Stent Diameter (Millimeter) · 378Stent Length (Millimeter) · 330Catheter Gauge (French) · 126Length (Centimeter) · 126Outer Diameter (Millimeter) · 126Stent Length (Centimeter) · 48

Use these as the dimensions to specify in a tender line.

How many polymer-metal oesophageal stent products are registered in the US?

1,006 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymer-metal oesophageal stent", from 8 companies. The largest labeler is Bcm Co., Ltd. with 46% of records.

Which FDA product codes apply?

ESW (Prosthesis, Esophageal), ESW (PROSTHESIS, ESOPHAGEAL)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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