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SKLAR INSTRUMENTS

USA · West Chester

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in Saudi Arabia, Canada, Australia — 3 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

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

34registered imported devices

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

CACanadaMDALL

47active device licences

Class II 47

84 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 States0 registration records, 0 510(k), 0 PMA, 4 excluded

Saudi Arabia34 confirmed, 1 excluded

Canada47 confirmed, 0 excluded

Manufacturer names merged into this page: SKLAR INSTRUMENTS · Sklar Instruments · SKLAR Instruments

Registration details (sample)

Market	Identifier	Name	Class / date
SA	ME0000006945SFDAA00038	BRUSH	—
SA	ME0000006945SFDAA00039	SklarLite™ Disposable paper filters	—
CA	18443	SUCTION TUBES	Class II
CA	18444	TONOMETERS	Class II
CA	18448	IRRIGATION CANNULA	Class II

SKLAR INSTRUMENTS

Registrations by market

How these numbers were verified

Company information

Registration details (sample)

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