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Roth Net 00711200

by US Endoscopy

Ref 00711200Model Roth Net 360- Non-Sterile

Roth Net 00711200 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 0724995ENROTHNET360NSBW), cleared under FDA 510(k) K182909 on 21 Nov 2018 and listed in FDA GUDID since 25 Nov 2024 (UDI-DI 00724995220051), active as of 24 Oct 2026.

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 found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K182909

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995ENROTHNET360NSBW Basic UDI-DI 00724995220051UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995220051 UDI-DI Date25 Nov 2024ListedStatusListed 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 0724995ENROTHNET360NSBW registered 20 Oct 2026 Active
  • FDA 510(k) K182909 decided 21 Nov 2018 Active
  • FDA GUDID UDI-DI 00724995220051 listed 25 Nov 2024 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K182909
  2. Listed FDA GUDID 00724995220051
  3. Registered EUDAMED 0724995ENROTHNET360NSBW

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  • Withdrawn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 360- Non-Sterile
Model / Ref / Catalog
00711200, Roth Net 360- Non-Sterile
Primary DI / UDI-DI
00724995220051
Basic UDI-DI
0724995ENROTHNET360NSBW
510(k) Number
FDA product code
FDI, GCJ
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
876.4300, 876.1500
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 2.5 Millimeter
Width — 3 Centimeter
Length — 230 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 (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

  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)