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Roth Net 00711162

by US Endoscopy

Ref 00711162Model Roth Net Foreign Body - Sterile

Roth Net 00711162 is a device classified as Class I in the EU and Class II in the US made by US Endoscopy, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 0724995ENROTHNETFBSLGM), cleared under FDA 510(k) K182909 on 21 Nov 2018 (1 earlier submission) and listed in FDA GUDID since 19 Mar 2020 (UDI-DI 00724995182731), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182909

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995ENROTHNETFBSLGM Basic UDI-DI 00724995182731UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995182731 UDI-DI Date19 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK182909 Date21 Nov 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0724995ENROTHNETFBSLGM registered 20 Oct 2026 Active
  • FDA 510(k) K182909 decided 21 Nov 2018 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00724995182731 listed 19 Mar 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-1416-2017 FDA Class III initiated 13 Dec 2016

    The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.

Timeline

5 dated events

  1. Cleared FDA 510(k) K122462
  2. Recall initiated FDA recalls Z-1416-2017
  3. Cleared FDA 510(k) K182909
  4. Listed FDA GUDID 00724995182731
  5. Registered EUDAMED 0724995ENROTHNETFBSLGM

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Roth Net
Generic name
Gastrointestinal/airway foreign body retrieval basket, single-use
Device name
Roth Net Foreign Body - Sterile
Model / Ref / Catalog
00711162, Roth Net Foreign Body - Sterile
Primary DI / UDI-DI
00724995182731
Basic UDI-DI
0724995ENROTHNETFBSLGM
510(k) Number
FDA product code
GCJ, FDI
EMDN code
G0305010202 Digestive endoscopy, retrieval basket devices, non-revolving
GMDN term
Gastrointestinal/airway foreign body retrieval basket, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500, 876.4300
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 2.5 Millimeter
Length — 230 Centimeter
Width — 3 Centimeter

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: Gastrointestinal/airway foreign body retrieval basket, single-use

Cleared under the same submission (K122462)

and 8 more cleared under K122462

Cleared under the same submission (K182909)

and 8 more cleared under K182909

Similar devices in this category

Other devices filed under DIGESTIVE ENDOSCOPY, RETRIEVAL BASKET DEVICES, NON-REVOLVING.

Other devices from US Endoscopy

See all devices from US Endoscopy →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)