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Persyst Development Corporation

USA · Solana Beach

✓ Record-verifiedregistrations found in 4 markets

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

4listed device types

Class I 0Class II 4Class III 0

plus 8 registration records and 11 510(k)

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

0active device licences

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 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 States8 registration records, 11 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: PERSYST DEVELOPMENT LLC

FDA 510(k) clearances by year

11998

12001

12011

12013

12014

12015

12017

12018

12022

22025

FDA listed device types

Non-Normalizing Quantitative Electroencephalograph Software 1Amplitude-Integrated Electroencephalograph 1Source Localization Software For Electroencephalograph Or Magnetoencephalograph 1Automatic Event Detection Software For Full-Montage Electroencephalograph 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252160	Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))	2025-10-31
US	K242446	Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))	2025-01-22
US	K222002	Persyst 15 EEG Review and Analysis Software	2022-12-30

Persyst Development 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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