Skip to content

SureGlide 15BX

by Gyrus Acmi, Inc.

Ref 15, 15BX

SureGlide 15BX is a device classified as Class IIa in the EU and Class I in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI B-00821925010314) and listed in FDA GUDID since 11 Sep 2018 (UDI-DI 00821925010314), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925010314 Basic UDI-DI Date24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925010314 UDI-DI Date11 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00821925010314 registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 00821925010314 listed 11 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00821925010314
  2. Registered EUDAMED B-00821925010314

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
SureGlide
Generic name
Gastro-urological guidewire, single-use
Device name
15
15BX
Model / reference
15BX, 15
Primary DI / UDI-DI
00821925010314, 00821925009752
Basic UDI-DI
B-00821925010314, B-00821925009752
FDA product code
EYA
EMDN code
U0601 Urological guidewires, hydrophilic
GMDN term
Gastro-urological guidewire, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
876.5130
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Gastro-urological guidewire, single-use

Similar devices in this category

Other devices filed under UROLOGICAL GUIDEWIRES, HYDROPHILIC.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)