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Guardus SI711146

by US Endoscopy

Ref SI711146Model Guardus Overtube - Non-sterile

Guardus SI711146 is a device classified as Class I in the EU and Class II in the US made by US Endoscopy, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI 0724995ENGUARDUSOTENSFV) and listed in FDA GUDID since 2 Apr 2020 (UDI-DI 00724995184483), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995ENGUARDUSOTENSFV Basic UDI-DI 00724995184483UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995184483 UDI-DI Date2 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724995ENGUARDUSOTENSFV registered 22 Sep 2026 Active
  • FDA GUDID UDI-DI 00724995184483 listed 2 Apr 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00724995184483
  2. Registered EUDAMED 0724995ENGUARDUSOTENSFV

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  • Withdrawn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
Guardus
Generic name
Endoscopic overtube, single-use
Device name
Guardus Overtube - Non-sterile
Model / Ref / Catalog
SI711146, Guardus Overtube - Non-sterile
Primary DI / UDI-DI
00724995184483
Basic UDI-DI
0724995ENGUARDUSOTENSFV
FDA product code
FED
EMDN code
G0199 Oro-oesophageal tubes - other
GMDN term
Endoscopic overtube, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 19.5 Millimeter
Length — 25 Centimeter
Lumen/Inner Diameter — 17 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Endoscopic overtube, single-use

Similar devices in this category

Other devices filed under ORO-OESOPHAGEAL TUBES.

Other devices from US Endoscopy

See all devices from US Endoscopy →

Properties

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