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Lucas Grason-Stadler, Inc.

USA · Milford

✓ Record-verifiedregistrations found in 6 markets

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

21510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

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

3active device licences

Class II 3

10 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

9device registrations

CLASS B 9

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 1

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 States0 registration records, 21 510(k), 0 PMA, 1 excluded

Brazil8 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: GRASON-STADLER · DIAGNOSTIC GROUP LLC - DBA GRASON-STADLER

Same-named companies — This database also contains companies with near-identical names: DIAGNOSTIC GROUP LLC - DBA GRASON-STADLER, Grason-Stadler, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K193033	GSI Audera Pro	2020-04-24
US	K180287	GSI Corti	2018-05-11
US	K172403	GSI Novus	2017-10-20
BR	80102511292	AUDIÔMETRO CLÍNICO GSI AUDIOSTAR PRO.	Class II
BR	80102511188	GSI 39 AUTO TYMP	Class II
BR	80102512437	Audiômetro	Class II
CA	61168	GSI AUDIOSCREENER+	Class II
CA	61235	GSI AUDERA	Class II
CA	61275	OTOACOUSTIC DEVICES	Class II

Lucas Grason-Stadler, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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