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DUPACO, INC.

USA · Oceanside

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel — 6 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

5listed device types

Class I 4Class II 1Class III 0

plus 6 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States6 registration records, 5 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Saudi Arabia9 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: DUPACO, INC. · Dupaco, Inc.

FDA 510(k) clearances by year

11977 · K770084

11982 · K821434

11983 · K830395

11984 · K841581

12015 · K150518

FDA listed device types

Shield, Eye, Radiological 1Fiber, Medical, Absorbent 1Support, Patient Position 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1System, Applicator, Radionuclide, Remote-Controlled 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K150518	Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm	2015-06-29
US	K841581	UNIFILTER ANESTHESIA & RESPIRATORY FILT	1984-04-30
US	K830395	PEEPER	1983-03-11
BR	80117580743	OPTI-GARD®	Class I
SA	ME0000009172SFDAA00001	Proneview Cushion Inserts	—
SA	ME0000009172SFDAA00003	D28510CE	—
CA	540	BLOOD FLUID WARMING SET	Class II
CA	3006	HEMOKINETITHERM/HEMOCOIL FLUID WARMING COIL	Class II

DUPACO, INC.

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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