Consulting Wallah › Device Explorer › Cardiovascular › Drug-eluting coronary artery stent, bioabsorbable-
Device Explorer · FDA GUDID · GMDN 58771

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

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

US‑registered devices154in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Boston Scientific Corporation8857%
Biotronik Ag6643%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation8857%
Biotronik Ag6643%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SYNERGY MEGATRON™SYNERGY™Orsiro Mission

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 stent206

GMDN & GCC registration

  • GMDN code 58771 · 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 Length (Millimeter) · 40Stent Diameter (Millimeter) · 40

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

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

154 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, bioabsorbable-polymer-coated", from 2 companies. The largest labeler is Boston Scientific Corporation with 57% of records.

Which FDA product codes apply?

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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