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Lake Region Mfg., Inc.

USA · Chaska

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Israel, Russia — 5 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

40listed device types

Class I 6Class II 29Class III 3unclassified 2

plus 118 registration records and 60 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class II 10

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

20 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 4Class 3 3

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 States118 registration records, 60 510(k), 0 PMA

Brazil10 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: LAKE REGION MEDICAL LIMITED · Lake Region Medical · LAKE REGION MEDICAL · LAKE REGION MEDICAL LTD. · LAKE REGION MEDICAL LTD

FDA 510(k) clearances by year

21996

21997

31998

22000

22001

22003

32004

22006

52008

12010

22011

22013

62014

12015

12016

12019

12021

12022

12024

12026

FDA listed device types

showing 8 of 40

Electrosurgical, Cutting & Coagulation & Accessories 1Apparatus, Cautery, Radiofrequency, Ac-Powered 1Endoscopic Guidewire, Gastroenterology-Urology 1Device, Neurovascular Embolization 1Unit, Phacofragmentation 1System, Balloon, Intra-Aortic And Control 1Catheter, Ureteral, Gastro-Urology 1Stent, Ureteral 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253746	Enroute 0.014'' Transcarotid Guidewire	2026-03-19
US	K242824	PTFE Guidewire	2024-12-06
US	K221575	Pre-Formed Blue	2022-10-07
BR	10341350486	FIO GUIA STARTER	Class II
BR	10341350737	FIO GUIA UROLÓGICO REVESTIDO EM PTFE	Class II
BR	10341350515	ZIPWIRE FIO GUIA HIDROFILICO	Class II
CA	9411	FLU VEN, IV SET	Class II
CA	104751	VISIONWIRE	Class II

Lake Region Mfg., 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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