Coloplast A S Mordrup Site

FDA Filings

This page includes the latest FDA filings for Coloplast A S Mordrup Site. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011307048
• FEI Number: 3011307048
• Name: Coloplast A/S - Mordrup Site
• Owner & Operator: Coloplast Corp.
• Contact Address: 1601 West River Road North ; Minneapolis MN 55411 US
• US Agent:
  • Dawn Sorensen
  • COLOPLAST CORP.
  • 612 3442476
  • usdms@coloplast.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Aa. Louis-Hansens Alle 15 ; Espergaerde Region Hovedstaden, 3060 DK
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K180258 | GBM Coloplast A/S - Mordrup Site [Coloplast Corp.]	SpeediCath	2019-01-21
PMN K143182 | GBM Coloplast A/S - Mordrup Site [Coloplast Corp.]	SpeediCath Compact Male	2015-02-02
PMN K143182 | GBM Coloplast A/S - Mordrup Site [Coloplast Corp.]	SpeediCath Compact Male with SpeediBag	2015-02-02
PMN K121458 | GBM Coloplast A/S - Mordrup Site [Coloplast Corp.]	SpeediCath Compact Male Set	2012-10-18
PMN K023254 | GBM Coloplast A/S - Mordrup Site [Coloplast Corp.]	SpeediCath	2008-01-10
EYJ Coloplast A/S - Mordrup Site [Coloplast Corp.]	CONVEEN GRIP CATH	2005-08-04