Consulting Wallah › Device Explorer › Procedure kits & trays › Varicose vein lasing procedure kit
Device Explorer · FDA GUDID · GMDN 47535

Varicose vein lasing procedure kit

A collection of sterile devices and materials designed to perform percutaneous laser treatment of varicose veins and varicosities associated with reflux in the superficial veins of the leg. It typically contains an entry needle, a laser fibre, an introducer sh

US‑registered devices87in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Teleflex Incorporated3844%
Angiodynamics, Inc.2731%
Vascular Solutions, Inc.1821%
Ceram Optec Sia45%

Top labelers

CompanyDevicesShare
Teleflex Incorporated3844%
Angiodynamics, Inc.2731%
Vascular Solutions, Inc.1821%
Ceram Optec Sia45%

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

Brand names on the register (sample)

Endovascular Laser Vein System (ELVeS®) KitVSIVARI-LASEVascular Solutions Custom Access KitVari-Lase® Flex laser fiber and procedure kitsVari-Lase® Platinum Bright Tip laser fiber and pVari-Lase® Platinum Bright Tip laser fiberAngioDynamicsVenaCure EVLTVenaCure

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

FDA product codes

CodeNameDevices
GEXPowered laser surgical instrument68
GEXPowered Laser Surgical Instrument35
KGZAccessories, Catheter1
DYBINTRODUCER, CATHETER1
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1

GMDN & GCC registration

  • GMDN code 47535 · non‑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 (Centimeter) · 71Needle Gauge (Gauge) · 60Catheter Gauge (French) · 34Outer Diameter (Millimeter) · 12

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

No closely related category with 50+ devices.

How many varicose vein lasing procedure kit products are registered in the US?

87 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Varicose vein lasing procedure kit", from 4 companies. The largest labeler is Teleflex Incorporated with 44% of records.

Which FDA product codes apply?

GEX (Powered laser surgical instrument), GEX (Powered Laser Surgical Instrument), KGZ (Accessories, Catheter), DYB (INTRODUCER, CATHETER)

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.

How do I get quotes?

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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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