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DALE MEDICAL PRODUCTS, INC.

USA · Franklin

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Australia, Hong Kong, Israel — 7 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

9listed device types

Class I 8Class II 1Class III 0

plus 9 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

13registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 4IIa 1

HKHong KongMDACS

1valid listings

Class II 1

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 States9 registration records, 14 510(k), 0 PMA, 2 excluded

Saudi Arabia13 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: DALE MEDICAL PRODUCTS, INC. · Dale Medical Products Inc. · Dale Medical Products, Inc.

FDA 510(k) clearances by year

11981

11983

11984

11986

21987

11989

21991

11995

11996

11997

12000

12008

FDA listed device types

showing 8 of 9

Binder, Abdominal 1Administration Set Securement Device 1Holder, Ureteral Catheter 1Device, Fixation, Tracheal Tube 1Scraper, Tongue 1Binder, Breast 1Tape And Bandage, Adhesive 1Splint, Extremity, Noninflatable, External, Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K082241	THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751	2008-10-30
US	K994300	NASOGASTRIC TUBE HOLDER, MODEL 160	2000-02-10
US	K964399	DALE ENDOTRACHEAL TUBE HOLDER 270/280	1997-01-28
SA	ME0000009159SFDAA00002	Bendable ArmBoard	—
SA	ME0000009159SFDAA00003	Stabilock Endotracheal Tube Holder	—
CA	88755	DALE ACE CONNECTOR	Class II

DALE MEDICAL PRODUCTS, 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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