Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012649202

FEI Number

3012649202

Entity Name

Centre de distribution Coloplast Le Plessis Pate

City/State/Country

Le Plessis-Pate Essonne, FR

Establishment Address

2 Rue Jacqueline Auriol, Le Plessis-Pate Essonne 91220, FR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

K182122

PMA Number

N/A

All Registered Proprietary Names

ReTrace Ureteral Access Sheath ReTrace Ureteral Access Sheath 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 BoNee Needle Biosoft Duo Double Loop Stent Kit Vortek Double Loop Ureteral Stents ReTrace Ureteral Access Sheath EasiVac Orchestra Hydrophilic Guidewire Chiba needle NovoFlow Reinforced Ureteral Stent ImaJin Silicone double loop ureteral stent kits ImaJin Pyelostent Silicone double loop ureteral stent kits ImaJin Stenostent Silicone double loop ureteral stent kits Ureteral Dilators and Percutaneous Nephrostomy Dilators Isiris ?; Isiris Monitor; Isiris Monitor Fixture; Isiris Monitor adaptor kit type G; Isiris Monitor adaptor kit-typ Floppy Tip Hydro-Coated Ureteric Catheters Flush Ureteric Catheters Ureteric Catheters Kolibri Percutaneous Nephrostomy Catheters Kolibri Percutaneous Nephrostomy Kits Kolibri Direct Puncture Sets KT RUP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2014-08-07
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-12-26
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-12-26
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2009-05-13
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2017-11-29
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2018-03-20
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-11-13
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	2007-07-11
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2015-07-06
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	1995-02-27
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2022-09-20
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2022-09-20
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2017-11-29
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-03-02
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2019-02-19
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2022-11-22
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2022-11-22
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2019-02-19

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
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-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012649202. Last updated year: 2026. Please use registration number 3012649202 when referencing this establishment in official correspondence.