EUDAMED device

Amielle Comfort

EUDAMED device 00384702100016 · Owen Mumford Ltd

Key facts

Primary DI 00384702100016
Trade name Amielle Comfort
Device name Amielle Comfort
Reference or catalog number SM2100
Model SM2100
Manufacturer Owen Mumford Ltd
Manufacturer SRN GB-MF-000021000
Risk class Class I
EMDN code L0509020101
EMDN description DILATATEURS VAGINAUX, RÉUTILISABLES|DILATATORI VAGINALI, RIUTILIZZABILI|VAGINAL DILATORS, REUSABLE
Legislation mdr
Implantable No
Sterile No
Single use No
Status date Mar 21, 2022

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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:

Browse all EUDAMED devices