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MONTERIS MEDICAL CORPORATION

USA · Minnetonka

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

7listed device types

Class I 2Class II 5Class III 0

plus 22 registration records and 21 510(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

1active device licences

Class IV 1

5 including historic records

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 States22 registration records, 21 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: MONTERIS MEDICAL CORP · MONTERIS MEDICAL CORPORATION

FDA 510(k) clearances by year

22009

12011

32013

22014

12015

12016

42017

12018

22020

22023

12024

12026

FDA listed device types

Coil, Magnetic Resonance, Specialty 1Neurosurgical Laser With Mr Thermography 1Neurological Stereotaxic Instrument 1Drills, Burrs, Trephines & Accessories (Simple, Powered) 1Powered Laser Surgical Instrument 1System, X-Ray, Film Marking, Radiographic 1Instrument, Surgical, Non-Powered 1

Market	Identifier	Name	Class / date
US	K260976	NeuroBlate System	2026-04-23
US	K240877	Monteris Medical NeuroBlate System	2024-06-04
US	K231061	NeuroBlate System	2023-12-08
CA	90932	AUTOLITT SYSTEM	Class IV

MONTERIS MEDICAL 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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