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Laborie Medical Technologies, Corp.

USA · Portsmouth

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

14listed device types

Class I 1Class II 13Class III 0

plus 25 registration records and 18 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

15registered devices

Class II 15

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

15active device licences

Class II 13Class III 2

86 including historic records

TWTaiwanTFDA

7valid device licences

Class I 5Class II 2

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

18active ARTG entries

IIa 16Class Im (measuring) 2

HKHong KongMDACS

5valid listings

Class II 5

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 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 States25 registration records, 18 510(k), 0 PMA, 3 excluded

Brazil15 confirmed, 0 excluded

Canada15 confirmed, 0 excluded

Manufacturer names merged into this page: LABORIE MEDICAL TECHNOLOGIES CORP. · LABORIE MEDICAL TECHNOLOGIES, CORP. · LABORIE MEDICAL TECHNOLOGIES EUROPE LIMITED. · Laborie Medical Technologies Canada ULC:

FDA 510(k) clearances by year

11992

31993

11994

21995

21996

11997

12007

22008

22009

32024

FDA listed device types

showing 8 of 14

Device, Cystometric, Hydraulic 1System, Image Processing, Radiological 1Stimulator, Electrical, Evoked Response 1Stimulator, Electrical, Non-Implantable, For Incontinence 1Endoscopic Injection Needle, Gastroenterology-Urology 1Uroflowmeter 1Cable, Electrode 1Electrode, Cutaneous 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241523	injeTAK Adjustable Tip Needle (DIS199; DIS201)	2024-08-27
US	K240007	Solar Compact (G4-1)	2024-05-06
US	K234107	Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)	2024-04-23
BR	80102519407	Sistema de aquisição de dados para Urodinâmica	Class II
BR	80102511676	Cateter de Manometria Anoretal T-DOC	Class II
BR	80102511691	Cateter Radiopaco Air-Charged T-DOC®	Class II
CA	3594	VAGINAL PRESSURE PROBE	Class II
CA	3597	ANAL PRESSURE PROBE	Class II
CA	6378	ENURESIS ALARM	Class II