Consulting Wallah › Device Explorer › Cardiovascular › Polymer-metal tracheal/bronchial stent
Device Explorer · FDA GUDID · GMDN 43630

Polymer-metal tracheal/bronchial stent

A non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. It is made of both metallic and synthetic polymer materials (e.g., metal mesh with a polymeric cover/lini

US‑registered devices308in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Micro-Tech (Nanjing) Co., Ltd.12340%
M.I.Tech Co., Ltd.8427%
Sewoon Medical Co., Ltd.8327%
Boston Scientific Corporation186%

Top labelers

CompanyDevicesShare
Micro-Tech (Nanjing) Co., Ltd.12340%
M.I.Tech Co., Ltd.8427%
Sewoon Medical Co., Ltd.8327%
Boston Scientific Corporation186%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tracheal Stent System (Y shaped)Tracheal Stent system (Y-shaped)Through the Scope Tracheal Stent SystemTracheal Stent system (OTW)BONASTENT® Tracheal/BronchialHANAROSTENT® Trachea/Bronchium(CCC)Ultraflex™ Tracheobronchial

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

FDA product codes

CodeNameDevices
JCTProsthesis, Tracheal, Expandable211
NSTAutoantibodies, Acetylcholine Receptor, Acetylcholine Blocki79
JCTProsthesis, tracheal, expandable52

GMDN & GCC registration

  • GMDN code 43630 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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) · 207Stent Length (Millimeter) · 204Shaft Length (Millimeter) · 3

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

How many polymer-metal tracheal/bronchial stent products are registered in the US?

308 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymer-metal tracheal/bronchial stent", from 4 companies. The largest labeler is Micro-Tech (Nanjing) Co., Ltd. with 40% of records.

Which FDA product codes apply?

JCT (Prosthesis, Tracheal, Expandable), NST (Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocki), JCT (Prosthesis, tracheal, expandable)

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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