EUDAMED device

OverStitch NXT™

EUDAMED device 00191506049096 · Boston Scientific Corporation

Key facts

Primary DI 00191506049096
Trade name OverStitch NXT™
Device name OverStitch ESS
Reference or catalog number M00505420
Manufacturer Boston Scientific Corporation
Manufacturer SRN US-MF-000004702
Risk class Class IIa
EMDN code G030899
EMDN description INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER
Legislation mdr
Implantable No
Sterile Yes
Single use Yes
Status date Oct 25, 2025

At a glance

  • No Matching FDA GUDID record

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About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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