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Guyon Catheter Introducer Curved 43 cm - 17" Tip Size 4.0 mm Stainless Steel

by Surtex Instruments Ltd United Kingdom EUDAMEDGUDID

Ref UR-521-04Model 50554459WIRESUTURIU06996E

Product code FZXEMDN U0699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05056111304938 UDI-DIDate12 May 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number50554459PROBEDILATE56 Basic UDI-DIDate16 Mar 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Guyon Catheter Introducer Curved 43 cm - 17" Tip Size 4.0 mm Stainless Steel EUDAMED
Surtex GUDID
Generic Name
Gastro-urological guidewire, reusable
Device Name
Probes & Dilators
Urological guidewires - other
Model / Reference
UR-521-04, 50554459WIRESUTURIU06996E
Primary DI / UDI-DI
05056111304938
Basic UDI-DI
50554459PROBEDILATE56, 50554459WIRESUTURIU06996E
FDA Product Code
FZX
EMDN Code
U0699 Urological guidewires - other
GMDN Term
Gastro-urological guidewire, reusable
Device Class
Class I
Regulation Number
878.4800
Market of Registration
Spain
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Manufacturer details

EUDAMED SRN
GB-MF-000023183
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Surtex Instruments Ltd

See all devices from Surtex Instruments Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable YesEUDAMEDNoEUDAMED
  • Premarket Exempt
Other properties (22)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 3f26df1f-0033-4126-b1da-9614d657cf52 61 fields · synced 22 Oct 2026
  • EUDAMED 05056111304938|50554459WIRESUTURIU06996E 61 fields · synced 14 Oct 2026
  • FDA UDI e921d752-d9bf-4e2e-9f3d-692c498149c2 34 fields · synced 22 Oct 2026