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Coloplast A.S.

Denmark · Humlebaek

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Hong Kong, Israel, Russia — 8 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

22listed device types

Class I 14Class II 6Class III 0unclassified 2

plus 35 registration records and 72 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

151registered devices

Class I 112Class II 39

181 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

42active device licences

Class II 35Class III 7

97 including historic records

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

17device registrations

CLASS B 3CLASS C 13D WITH MEDICINAL PRODUCT 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

20valid listings

Class II 3Class III 13Class IV 4

ILIsraelAMAR

30registrations

RURussiaRoszdravnadzor

45active registrations

Class 1 22Class 2a 11Class 2b 12

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 States35 registration records, 72 510(k), 0 PMA, 13 excluded

Brazil151 confirmed, 6 excluded

Canada42 confirmed, 4 excluded

Manufacturer names merged into this page: COLOPLAST A/S

FDA 510(k) clearances by year

21986

31987

21988

11989

31990

61992

11993

21995

42009

42010

32011

82012

32013

22014

42015

22018

12020

12022

12023

12026

FDA listed device types

showing 8 of 22

Ostomy Care Kit 1Device, Incontinence, Urosheath Type, Non-Sterile 1Scissors, Medical, Disposable 1Catheter, Continuous Irrigation 1Enema Kit 1Solvent, Adhesive Tape 1Dressing, Wound, Occlusive 1Bag, Urine Collection, Leg, For External Use, Non-Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262045	Luja Soft	2026-07-07
US	K221874	Altis Single Incision Sling System	2023-02-15
US	K220420	Saffron Fixation System	2022-06-10
BR	10430310015	COMFEEL PLUS CURATIVO DE CONTORNO	Class II
BR	10430310017	COMFEEL PLUS CURATIVO ALIVIADOR DE PRESSAO	Class II
BR	10430319032	CONVEEN FITA REAJUSTAVEL DE PERNA COLOPLAST	Class I
CA	2679	SILICONE ELASTOMER TESTICULAR PROSTHESIS	Class III
CA	6348	CONVEEN INTERMITTENT CATHETER	Class II
CA	12276	CYSTO-CARE - UROLOGICAL PROCEDURE TRAYS	Class II

Coloplast A.S.

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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