Coloplast Manufacturing France S A S

FDA Filings

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

FDA Registration(s)

• Registration Number: 3012649202
• FEI Number: 3012649202
• Name: Coloplast Manufacturing France S.A.S
• Owner & Operator: Coloplast Corp.
• Contact Address: 1601 West River Road North ; Minneapolis MN 55411 US
• US Agent:
  • Dawn Sorensen
  • COLOPLAST CORP.
  • 612 3442476
  • usktok@coloplast.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: ZAC du Clotais 2b, Route du Chemin Blanc; Champlan Essonne, 91160 FR
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
PMN K181811 | FED Coloplast Manufacturing France S.A.S [Coloplast Corp.]	ReTrace Ureteral Access Sheath	2019-12-26
OCY Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Seldinger Guidewire	2019-12-26
PMN K180469 | FAD Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Silicone Hydro-Coated Double Loop Ureteral Stent	2019-03-21
PMN K182122 | EYB Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Ureteric Catheter	2019-02-19
PMN K171043 | EYB Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Ureteric Catheters	2019-02-19
PMN K171043 | EYB Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Flush Ureteric Catheters	2019-02-19
PMN K171043 | EYB Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Floppy Tip Hydro-Coated Ureteric Catheters	2019-02-19
PMN K180057 | FAD Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Vortek? Double Loop Ureteral Stents	2018-03-20
PMN K170362 | FAD Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Vortek Hydro-coated double loop stent	2018-01-17
PMN K170531 | EZN Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Ureteral Dilator, Percutaneous Nephrostomy Dilators	2017-11-29
PMN K170422 | FAD Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Biosoft duo Double Loop Ureteral Stent	2017-11-29
PPG Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Ureteral Stent Kit	2017-05-03
PPG Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Silicone Double Loop Ureteral Stent Kit	2017-05-03
PMN K160766 | FAJ Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Isiris? ?; Isiris? Monitor; Isiris? Monitor Fixture; Isiris? Monitor adaptor kit type G; Isiris? Monitor adaptor kit-typ	2017-03-02
PMN K013921 | FAD Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Vortek	2001-12-04
PMN K013921 | FAD Coloplast Manufacturing France S.A.S [Coloplast Corp.]	VORTEK AND SILICONE	2001-12-04
PMN K013921 | FAD Coloplast Manufacturing France S.A.S [Coloplast Corp.]	ImaJin	2001-12-04
PMN K013921 | FAD Coloplast Manufacturing France S.A.S [Coloplast Corp.]	Biosoft	2001-12-04