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PRECISION MEDICAL, INC.

USA · Northampton

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, 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

13listed device types

Class I 4Class II 9Class III 0

plus 19 registration records and 30 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

7active device licences

Class II 7

35 including historic records

TWTaiwanTFDA

5valid device licences

Class I 3Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

7registrations

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 States19 registration records, 30 510(k), 0 PMA, 279 excluded

Brazil0 confirmed, 27 excluded

Saudi Arabia1 confirmed, 8 excluded

Canada7 confirmed, 11 excluded

Manufacturer names merged into this page: PRECISION MEDICAL, INC. · PRECISION MEDICAL INC. · Precision Medical,Inc.

FDA 510(k) clearances by year

11984

31985

51990

41993

41994

11998

12001

12003

12004

12005

12006

12007

12008

12009

22011

12014

12018

FDA listed device types

showing 8 of 13

Mixer, Breathing Gases, Anesthesia Inhalation 1Bottle, Collection, Vacuum 1Analyzer, Gas, Oxygen, Gaseous-Phase 1Humidifier, Respiratory Gas, (Direct Patient Interface) 1Generator, Oxygen, Portable 1Compressor, Air, Portable 1Regulator, Vacuum 1Conserver, Oxygen 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K173807	Accu O2 Oxygen Analyzer	2018-05-02
US	K140179	EASY GO VAC	2014-04-25
US	K103563	PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150	2011-07-01
SA	ME0000013393SFDAA00007	Easy Dial Reg - Easy gauge Reg	—
CA	61691	PM6 MINIMATE COMPRESSOR	Class II
CA	61782	EASY PULSE OXYGEN CONSERVER	Class II
CA	67723	EASYMATE LIQUID OXYGEN SYSTEM	Class II

PRECISION MEDICAL, 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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