Coloplast Manufacturing US LLC

FDA Device Registration & Listing · Burnsville, MN, US · Registration 3032906574

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3032906574
FEI Number
3032906574
Entity Name
Coloplast Manufacturing US LLC
City/State/Country
Burnsville, MN, US
Establishment Address
680 E Travelers Trl Ste 800, Burnsville, MN 55337, 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
N
Expiration Date (Year)
2026
510(k) Number
K173501
PMA Number
N/A

All Registered Proprietary Names

Meridian Vaginal Positioning System (VPS)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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

Official Correspondent

Brian Schmidt

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
3030087693 Coloplast Manufacturing US, LLC. Brookshire, TX, US
3008262278 Coloplast Hungary, KFT Tatabanya, HU
9610711 COLOPLAST MANUFACTURING FRANCE, SAS Sarlat la Caneda Cedex Dordogne, FR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032906574. Last updated year: 2026. Please use registration number 3032906574 when referencing this establishment in official correspondence.
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