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Baylis Medical Technologies, Inc.

Canada · Mississauga

✓ Record-verifiedregistrations found in 4 markets

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

10listed device types

Class I 0Class II 10Class III 0

plus 16 registration records and 58 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

24active device licences

Class II 17Class III 3Class IV 4

47 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class III 1

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 States16 registration records, 58 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada24 confirmed, 0 excluded

Manufacturer names merged into this page: BAYLIS MEDICAL TECHNOLOGIES INC. · BAYLIS MEDICAL COMPANY INC.

Business registration

Legal name: BAYLIS MEDICAL TECHNOLOGIES INC.
Corporation number: 11998005
Registration status: Active
Legal form: Canada Business Corporations Act
Incorporated: 2020-04-09
Registered address: 2645 Matheson Boulevard East, Mississauga, ON, L4W 5S4

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

32003

12005

12006

32007

12008

22009

32010

22011

22012

22013

42015

12016

12017

72019

12020

32022

42023

32024

32025

12026

FDA listed device types

showing 8 of 10

Electrosurgical, Cutting & Coagulation & Accessories 1Catheter, Peripheral, Atherectomy 1Probe, Radiofrequency Lesion 1Cable, Electrode 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Wire, Guide, Catheter 1Generator, Lesion, Radiofrequency 1Catheter, Septostomy 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254114	Baylis Connector Cable	2026-01-18
US	K250275	PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch	2025-10-28
US	K251158	PowerWire® 14 Radiofrequency Guidewire Kit	2025-09-11
BR	80065320074	FIO GUIA PARA RADIO FREQUENCIA POWER-WIRE	Class II
CA	74023	BAYLIS PAIN MANAGEMENT DISPERSIVE ELECTRODE	Class II
CA	74750	PAIN MANAGEMENT SINGLE-USE PROBES	Class II
CA	64468	BAYLIS RADIO FREQUENCY PAIN MANAGEMENT SYSTEM	Class III

Baylis Medical Technologies, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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