Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610711

FEI Number

3002807917

Entity Name

COLOPLAST MANUFACTURING FRANCE, SAS

City/State/Country

Sarlat la Caneda Cedex Dordogne, FR

Establishment Address

9 Avenue Edmond Rostand, CS 70218, Sarlat la Caneda Cedex Dordogne 24206, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Coloplast Corp. (Owner Number: 8010144)

Owner / Operator Contact Address

1601 West River Road North, Minneapolis, MN 55411, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090217

PMA Number

N/A

All Registered Proprietary Names

Kolibri Percutaneous Nephrostomy Catheters Kolibri Percutaneous Nephrostomy Kits Kolibri Direct Puncture Sets Ureteral Dilators and Percutaneous Nephrostomy Dilators Elefant Suction-Irrigation Device Silicone Prostatectomy Catheter Orchestra Hydrophilic Guidewire EasiVac Biosoft Duo Double Loop Stent Kit Dormia No Tip Dornia N-Stone Dormia DualPerc Floppy Tip Hydro-Coated Ureteric Catheters Flush Ureteric Catheters Ureteric Catheters ImaJin Silicone double loop ureteral stent kits ImaJin Pyelostent Silicone double loop ureteral stent kits ImaJin Stenostent Silicone double loop ureteral stent kits ReTrace Ureteral Access Sheath Vortek Double Loop Ureteral Stents Vortek Hydrocoated Double Loop Ureteral Stent Seldinger Guidewire Soprano Hybrid Guidewire Soprano® Dual Flex-PTFE-Nitinol Guidewire with Straight Hydrophilic Tip with Insertion Tool Soprano®-PTFE-Nitinol Guidewire with Straight Hydrophilic Tip with Insertion Tool Vortek Single Loop Ureteral Stent ReTrace Ureteral Access Sheath Imajin Silicone Hydro-Coated Double Loop Ureteral Stent BoNee Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2022-11-22
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2022-11-22
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2017-11-29
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2001-12-04
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2008-01-08
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2015-07-06
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	2007-07-11
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2017-11-29
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	1995-08-14
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2019-02-19
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2022-09-20
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2014-08-07
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2018-03-20
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2018-01-17
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-12-26
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2021-08-19
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-11-13
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2019-03-21
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2009-05-13

Official Correspondent

No official correspondent registered.

US Agent Details

Brian Schmidt Business: COLOPLAST CORP Email: usbes@coloplast.com Phone: (612) 8651177

Related Public Records

Same Entity

Coloplast Corp.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011307048	Coloplast A/S - Mordrup Site	Espergaerde Hovedstaden, DK
3005945907	COLOPLAST (CHINA) LTD.	ZHUHAI Guangdong, CN
3032906574	Coloplast Manufacturing US LLC	Burnsville, MN, US
3030087693	Coloplast Manufacturing US, LLC.	Brookshire, TX, US
3008262278	Coloplast Hungary, KFT	Tatabanya, HU

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
Z-0038-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
Z-0039-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
Z-0040-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
Z-0041-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

Similar Registrations

Registration Number	Establishment Name	Location
3019946783	RETROPERC, INC.	Jersey City, NJ, US
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3010155661	Synergy Health Sterilisation UK Ltd	Thorne Doncaster, GB
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
2126666	Lake Region Medical	CHASKA, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610711. Last updated year: 2026. Please use registration number 9610711 when referencing this establishment in official correspondence.