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Bio.Logic, Inc.

USA · Spokane

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

2listed device types

Class I 2Class II 0Class III 0

plus 2 registration records and 50 510(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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States2 registration records, 50 510(k), 0 PMA, 8 excluded

Saudi Arabia0 confirmed, 1 excluded

Manufacturer names merged into this page: BIO-LOGIC AQUA RESEARCH TECHNOLOGIES INT.. INC

FDA 510(k) clearances by year

21986

31987

41988

21989

11990

11993

31994

31995

41996

21997

31998

21999

22000

12001

32002

32003

12005

12006

12008

22012

FDA listed device types

Humidifier, Non-Direct Patient Interface (Home-Use) 1First Aid Kit Without Drug 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K122496	AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM	2012-11-01
US	K121512	SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM	2012-07-26
US	K073626	BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM	2008-02-05

Bio.Logic, Inc.

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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