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Meditech International, Inc.

Canada · Toronto

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 3 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

4listed device types

Class I 1Class II 3Class III 0

plus 7 registration records and 5 510(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

8 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIa 2IIb 2

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 States7 registration records, 5 510(k), 0 PMA, 80 excluded

Brazil0 confirmed, 30 excluded

Saudi Arabia0 confirmed, 7 excluded

Canada0 confirmed, 9 excluded

Manufacturer names merged into this page: Meditech International Inc · MEDITECH INTERNATIONAL INC.

FDA 510(k) clearances by year

12003 · K023621

12005 · K041885

12006 · K051875

22008 · K081355

FDA listed device types

Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy 1Lamp, Infrared, Therapeutic Heating 1Powered Laser Surgical Instrument 1Massager, Therapeutic, Electric 1

Market	Identifier	Name	Class / date
US	K081355	BIOFLEX LD-R100 TREATMENT HEAD	2008-12-18
US	K072551	LD-I 75 AND LD-I 200	2008-04-02
US	K051875	BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS	2006-03-13

Meditech International, 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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