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INSTRUMENTATION INDUSTRIES, INCORPORATED

USA · Bethel Park

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, Israel — 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

24listed device types

Class I 13Class II 11Class III 0

plus 31 registration records and 45 510(k), 3 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

2active device licences

Class II 2

25 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

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 States31 registration records, 45 510(k), 3 PMA, 47 excluded

Brazil0 confirmed, 8 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada2 confirmed, 5 excluded

Manufacturer names merged into this page: INSTRUMENTATION INDUSTRIES, INCORPORATED · INSTRUMENTATION INDUSTRIES, INC.

FDA 510(k) clearances by year

81977

21981

51982

31983

31986

31987

11988

11989

41997

31998

31999

12000

22008

12009

22010

12012

12017

12019

FDA listed device types

showing 8 of 24

Mouthpiece, Breathing 1Laryngoscope, Rigid 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Drain, Tee (Water Trap) 1Connector, Airway (Extension) 1Set, Tubing And Support, Ventilator (W Harness) 1Mask, Oxygen 1Bag, Reservoir 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180510	NS 120P-TRS Airway Pressure Gauge	2019-05-01
US	K162753	RTC 26-C Inline Aerosol Adapter	2017-02-28
US	K113644	PILOT TUBE REPAIR KIT	2012-01-26
CA	4998	ADAPTER/CONNECTOR - POLYSULFONE	Class II
CA	3013	EXHALATION VALVE	Class II

INSTRUMENTATION INDUSTRIES, INCORPORATED

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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