Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2125050

FEI Number

2125050

Entity Name

COLOPLAST MANUFACTURING US, LLC

City/State/Country

MINNEAPOLIS, MN, US

Establishment Address

1601 W River Rd N, MINNEAPOLIS, MN 55411, US

Establishment Type(s)

Repack or Relabel 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

K213185

PMA Number

N/A

All Registered Proprietary Names

Torosa Saline-Filled Testicular Prosthesis Altis Single Incision Sling System Meridian Restorelle Y NovoFlow Reinforced Ureteral Stent Saffron Fixation System Furlow Insertion Tool Brooks Dilator Set Rossello Dilator Set Imajin Silicone Hydro-Coated Double Loop Ureteral Stent Genesis Malleable Penile Prosthesis Restorelle Y Contour Restorelle M Restorelle XL Aris Transobturator Kit SabreLine and SabreGuard Laser Fibers Vortek Double Loop Ureteral Stents Meridian Vaginal Positioning System (VPS) Virtue Male Sling System with Alexis Wound Retractor Digitex Suture Delivery System Supris Retropubic Sling System Vortek Hydrocoated Double Loop Ureteral Stent Restorelle L ImaJin Silicone double loop ureteral stent kits ImaJin Pyelostent Silicone double loop ureteral stent kits ImaJin Stenostent Silicone double loop ureteral stent kits

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAF	Prosthesis, Testicular	Gastroenterology, Urology	Class 3	876.3750	2008-01-10
PAH	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling	General, Plastic Surgery	Class 2	878.3300	2025-04-02
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2014-02-19
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2012-06-21
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2022-09-20
PBQ	Fixation, Non-Absorbable Or Absorbable, For Pelvic Use	Obstetrics/Gynecology	Class 2	884.4530	2022-08-11
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2004-04-28
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2019-03-21
FAE	Prosthesis, Penile	Gastroenterology, Urology	Class 2	876.3630	2008-01-10
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2014-03-25
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2014-03-25
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2008-01-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-06-24
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2018-03-20
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2018-04-13
PWK	Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse	Obstetrics/Gynecology	Class 2	884.4910	2018-04-13
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2024-11-21
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male	General, Plastic Surgery	Class 2	878.3300	2024-11-21
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2012-06-21
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2012-06-21
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2011-12-20
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2018-01-17
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2012-11-26
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2022-09-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K900371	Mentor Corp.	MENTOR MODIFIED MALLEABLE PENILE PROSTHESES	1990-11-02
K222293	Urocure, LLC	ArcSP Suprapubic Sling System	2022-09-21
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2125050. Last updated year: 2026. Please use registration number 2125050 when referencing this establishment in official correspondence.