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MEDITECH KFT.

Hungary · Budapest

✓ Record-verifiedregistrations found in 5 markets

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

1listed device types

Class I 0Class II 1Class III 0

plus 2 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

9active device licences

Class II 9

14 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

1valid listings

Class II 1

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 States2 registration records, 2 510(k), 0 PMA, 32 excluded

Brazil1 confirmed, 12 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada9 confirmed, 7 excluded

Manufacturer names merged into this page: MEDITECH KFT. · MEDITECH KFT

Registration details (sample)

Market	Identifier	Name	Class / date
US	K071960	MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05	2007-08-03
US	K051149	MEDITECH MODEL ABPM-04	2005-11-18
BR	80303610020	CARD(x)PLORE	Class II
CA	31286	MERLIN EVENT RECORDER	Class II
CA	64486	CARDIOTENS	Class II
CA	64496	E-LITE ECG	Class II

MEDITECH KFT.

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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