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Coloplast Manufacturing US, LLC.

USA · Minneapolis

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

26listed device types

Class I 9Class II 14Class III 2unclassified 1

plus 38 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class II 2Class III 3

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States38 registration records, 4 510(k), 0 PMA, 12 excluded

Brazil1 confirmed, 6 excluded

Canada5 confirmed, 4 excluded

Manufacturer names merged into this page: COLOPLAST MANUFACTURING US, LLC · Coloplast Manufacturing US, LLC. · Coloplast Manufacturing US LLC

FDA 510(k) clearances by year

12007 · K070939

12008 · K082640

22010 · K100878

FDA listed device types

showing 8 of 26

Suture, Surgical, Absorbable, Polydioxanone 1Irrigator, Ostomy 1Fixation, Non-Absorbable Or Absorbable, For Pelvic Use 1Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator 1Stent, Ureteral 1Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling 1Cannula, Manipulator/Injector, Uterine 1Prosthesis, Penile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K100878	SELF CATH CATHETER	2010-05-26
US	K093112	DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE	2010-02-01
US	K082640	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM	2008-10-17
BR	10430310039	PERISTEEN GEL	Class II
CA	8111	URETHRIN INJECTION FOR TREATMENT OF URINARY INCONTINENCE	Class III
CA	13591	MARK II INFLATABLE PENILE PROSTHESIS	Class III
CA	14750	MENTOR POLYTEF PASTE FOR INJECTION	Class III

Coloplast Manufacturing US, LLC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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