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Pro-Tech, Inc.

USA · Woodinville

✓ Record-verifiedregistrations found in 4 markets

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

84listed device types

Class I 17Class II 45Class III 21unclassified 1

plus 117 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

31registered imported devices

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

CACanadaMDALL

0active device licences

13 including historic records

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

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 States117 registration records, 15 510(k), 0 PMA, 80 excluded

Brazil0 confirmed, 23 excluded

Saudi Arabia31 confirmed, 4 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: PRO-TECH DESIGN & MFG., INC. · PRO-TECH Design & Mfg, Inc. · PRO-TECH INTERNATIONAL · EMP TECH PRO INC · PRO-TECH SERVICES, INC. · Pro-Tech Services Inc.

Business registration

Legal name: ALPHA PRO TECH LTD
CIK: 0000884269
Registration status: Active
Listing status: Listed (APT)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11981

31992

11993

21994

21995

11996

11997

11998

12002

12004

12005

FDA listed device types

showing 8 of 84

Orthosis, Limb Brace 1Knife, Ophthalmic 1Orthosis, Lumbar 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Orthosis, Abdominal 1Orthosis, Truncal/Orthosis, Limb 1Adaptor, Holder, Syringe 1Kit, Surgical Instrument, Disposable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K053063	PRO-FLOW MULTIPURPOSE CANNULA	2005-12-13
US	K033402	PORTABLE SLEEP DATA RECORDER (PSDR)	2004-06-30
US	K013905	MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS	2002-04-22
SA	ME0000008121SFDAA00001	Pro-Flow Nasal Oral Cannula, Adult	—
SA	ME0000008121SFDAA00002	zRIP DuraBelt Kit, Adult, Alice 6	—

Pro-Tech, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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