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Guyon Catheter Introducer Straight 46 cm - 18" Stainless Steel

by Surtex Instruments Ltd

Ref UR-519-02Model 50554459WIRESUTURIU06996E

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05055445963125 UDI-DI Date12 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number50554459PROBEDILATE56 Basic UDI-DI 05055445963125UDI-DIDate16 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Guyon Catheter Introducer Straight 46 cm - 18" Stainless Steel EUDAMED
Surtex GUDID
Generic Name
Gastro-urological guidewire, reusable
Device Name
Probes & Dilators
Urological guidewires - other
Model / Reference
UR-519-02, 50554459WIRESUTURIU06996E
Primary DI / UDI-DI
05055445963125
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
EU market of registration
Spain
GUDID distribution status
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

  • 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