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Coloplast Hungary, KFT

Hungary · Tatabanya

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, South Korea — 4 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

27listed device types

Class I 14Class II 11Class III 0unclassified 2

plus 47 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 12Class II 2

15 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

11valid device licences

Class I 11

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

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 States47 registration records, 0 510(k), 0 PMA, 14 excluded

Brazil14 confirmed, 5 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: Coloplast Hungary, KFT · COLOPLAST HUNGARY KFT · COLOPLAST HUNGARY KFT - TATABÁNYA

FDA listed device types

showing 8 of 27

Bandage, Liquid, Skin Protectant 1Ostomy Care Kit 1Device, Incontinence, Urosheath Type, Non-Sterile 1Scissors, Medical, Disposable 1Catheter, Continuous Irrigation 1Solvent, Adhesive Tape 1Enema Kit 1Dressing, Wound, Occlusive 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10430310015	COMFEEL PLUS CURATIVO DE CONTORNO	Class II
BR	10430310017	COMFEEL PLUS CURATIVO ALIVIADOR DE PRESSAO	Class II
BR	10430319015	MC 2000 SISTEMA DE UMA PECA PARA OSTOMIA COLOPLAST	Class I

Coloplast Hungary, KFT

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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