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COLOPLAST CORPORATION

USA · Marietta

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel — 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

69510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 69 510(k), 89 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 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 5

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

118active ARTG entries

Class I 67Class III 3IIa 19IIb 13Class Is (sterile) 16

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States0 registration records, 69 510(k), 89 PMA, 14 excluded

Brazil1 confirmed, 6 excluded

Canada5 confirmed, 3 excluded

Manufacturer names merged into this page: COLOPLAST CORP · COLOPLAST CORPORATION · COLOPLAST CO LTD

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252140	Heylo System	2025-10-06
US	K251116	Luja Coudé	2025-06-27
US	K250270	Luja Set	2025-04-17
BR	10430319044	COLOPLAST ALTERNA BOLSA PARA COLOSTOMIA EACESSORIOS	Class I
CA	6352	COLOPLAST IRRIGATION SET	Class II
CA	21958	COMFEEL FILM - TRANSPARENT ADHESIVE DRESSING	Class II
CA	33170	P.S.P.	Class II

COLOPLAST CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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