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Medionics International , Ltd.

Canada · Markham

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, South Korea, Hong Kong, Israel — 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

2listed device types

Class I 1Class II 1Class III 0

plus 3 registration records and 10 510(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

6active device licences

Class II 4Class III 2

20 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

1registrations

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 States3 registration records, 10 510(k), 0 PMA

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: MEDIONICS INTERNATIONAL, INC. · MEDIONICS INTERNATIONAL INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130441	FALLER STYLET	2013-04-19
US	K993149	PERITONEAL DIALYSIS CATHETERS AND ADAPTERS	2000-04-28
US	K994218	EASY CARE AND TUBING SETS	2000-02-10
CA	16702	PERITONEAL DIALYSIS MACHINES, TUBINGS AND ACCESSORIES	Class III
CA	16715	C.A.P.D. AUTOMATIC HEATER	Class II
CA	37236	INJECTION CAP (LUER LOCK)	Class II

Medionics International , Ltd.

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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