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KING SYSTEMS CORPORATION.

USA · Noblesville

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, 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

11listed device types

Class I 9Class II 2Class III 0

plus 15 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

12active device licences

Class II 12

27 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

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 States15 registration records, 18 510(k), 0 PMA, 37 excluded

Brazil2 confirmed, 2 excluded

Canada12 confirmed, 1 excluded

Manufacturer names merged into this page: KING SYSTEMS CORPORATION. · KING SYSTEMS · KING SYSTEMS CORPORATION

FDA 510(k) clearances by year

41988

21993

11994

31995

11998

11999

12000

22001

12003

22004

FDA listed device types

showing 8 of 11

Anesthesia Breathing Circuit Kit (Adult & Pediatric) 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Connector, Airway (Extension) 1Set, Tubing And Support, Ventilator (W Harness) 1Bag, Reservoir 1Airway, Oropharyngeal, Anesthesiology 1Tubing, Pressure And Accessories 1Mask, Gas, Anesthetic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K033189	KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305	2004-05-04
US	K033186	KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205	2004-04-14
US	K021634	KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105	2003-01-09
BR	10330520052	MÁSCARA DE ANESTESIA	Class II
BR	10273820049	Máscara Facial King para VNI	Class II
CA	3027	FACE MASKS	Class II
CA	3032	TUBING	Class II
CA	3035	KAB CO2 ABSORBER	Class II

KING SYSTEMS CORPORATION.

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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