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Dukal Corporation

USA · Hauppauge

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

89listed device types

Class I 73Class II 11Class III 0unclassified 5

plus 96 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

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

1active device licences

Class II 1

14 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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 States96 registration records, 20 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: DUKAL LLC · DUKAL CORPORATION

FDA 510(k) clearances by year

11993

21994

11996

21997

11999

12002

12006

22007

12009

12012

22021

32022

12024

12026

FDA listed device types

showing 8 of 89

Cap, Surgical 1Pad, Eye 1Forceps 1Gauze / Sponge,Nonresorbable For External Use 1Scissors, Medical, Disposable 1Evacuator, Oral Cavity 1Stool, Operating-Room 1Syringe, Restorative And Impression Material 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252823	Dukal Crepe Paper Sterilization Wrap	2026-05-28
US	K233262	Dukal SMS Sterilization Wrap	2024-03-22
US	K212464	Dukal Corporation AAMI Level 4 Open-Back Protective Gown	2022-03-30
BR	81055829001	Capseus - BDC15	Class II
BR	80535240064	CURATIVO ADESIVO	Class I
BR	80801630003	Compressa de Gaze AllPrime	Class II
CA	3560	ROUNDSTICK SPONGES 1 1/4", X-RAY DETECTABLE	Class II

Dukal Corporation

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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