Consulting Wallah › Device Explorer › Cardiovascular › Drug-eluting coronary artery stent, non-bioabsorba
Device Explorer · FDA GUDID · GMDN 56284

Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a pati

US‑registered devices682in 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

Abbott Vascular Inc.26339%
Medtronic, Inc.20730%
Boston Scientific Corporation16023%
Medinol Ltd.528%

Top labelers

CompanyDevicesShare
Abbott Vascular Inc.26339%
Medtronic, Inc.20730%
Boston Scientific Corporation16023%
Medinol Ltd.528%

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

Brand names on the register (sample)

EluNIR-PERL Ridaforolimus Eluting Coronary StentOnyx Frontier™Resolute Onyx™XIENCE Skypoint™XIENCE Sierra™XIENCE ALPINEXIENCE XPEDITIONSYNERGY™ XDPromus ELITE™SYNERGY™

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

FDA product codes

CodeNameDevices
NIQCoronary drug-eluting stent1,050
NIQCoronary Drug-Eluting Stent104

GMDN & GCC registration

  • GMDN code 56284 · 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

Length (Millimeter) · 362Stent Diameter (Millimeter) · 275Stent Length (Millimeter) · 274Lumen/Inner Diameter (Millimeter) · 95Shaft Length (Millimeter) · 1Lumen/Inner Diameter (Micrometer) · 1

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

How many drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated products are registered in the US?

682 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated", from 4 companies. The largest labeler is Abbott Vascular Inc. with 39% of records.

Which FDA product codes apply?

NIQ (Coronary drug-eluting stent), NIQ (Coronary Drug-Eluting Stent)

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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