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Pascal International, Inc.

USA · Bellevue

✓ Record-verifiedregistrations found in 6 markets

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

17listed device types

Class I 14Class II 2Class III 0unclassified 1

plus 17 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class 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

0active device licences

TWTaiwanTFDA

6valid device licences

Class I 4Class II 2

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States17 registration records, 0 510(k), 0 PMA, 4 excluded

Brazil3 confirmed, 2 excluded

Manufacturer names merged into this page: Pascal International, Inc. · PASCAL INTERNATIONAL, INC.

Market	Identifier	Name	Class / date
BR	10320749016	Fio Retrator Não Medicado	Class II
BR	10320740036	Fio Retrator SA	Class I
BR	81481079001	Fio Retrator Gengival Não Medicado KnitTrax	Class II

Pascal International, Inc.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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