EUDAMED device

Colonic Balloon Dilator

EUDAMED device 00827002225459 · Wilson-Cook Medical, Inc.

Key facts

Primary DI 00827002225459
Trade name Colonic Balloon Dilator
Reference or catalog number QDC-18X5.5
Model Non-Sterile Balloon Dilators
Manufacturer Wilson-Cook Medical, Inc.
Manufacturer SRN US-MF-000002658
Risk class Class I
EMDN code G03010199
EMDN description GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER
Legislation mdr
Implantable No
Sterile No
Single use Yes
Status date Jun 1, 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:

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