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Guidewire

by Galt Medical Corp. EUDAMEDGUDID

Active European Union

Ref SGW-022-69Model SGW-XXX-xx

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00841268110366 UDI-DIDate19 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08412681Guidewires<90cm2K Basic UDI-DIDate4 May 2022RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 26 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Peripheral vascular guidewire, manual
Model / Ref / Catalog
SGW-XXX-xx, SGW-022-69
Primary DI / UDI-DI
00841268110366
Basic UDI-DI
08412681Guidewires<90cm2K
FDA Product Code
DQX
EMDN Code
C04020199 Peripheral vascular diagnostic guidewires- other
GMDN Term
Peripheral vascular guidewire, manual
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1330
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Outer Diameter — 0.018 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000001777
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Galt Medical Corp.

See all devices from Galt Medical Corp. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No