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MESI, DEVELOPMENT OF MEDICAL DEVICES, LTD.

Slovenia · Ljubljana

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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

4510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 4 510(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

5valid device licences

Class II 5

SGSingaporeHSA SMDR

6device registrations

CLASS B 6

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

2registrations

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 States0 registration records, 4 510(k), 0 PMA, 2 excluded

Brazil0 confirmed, 1 excluded

Manufacturer names merged into this page: MESI, DEVELOPMENT OF MEDICAL DEVICES, LTD.

Same-named companies — This database also contains companies with near-identical names: Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd., Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223670	MESI mTablet ECG Diagnostic System, MESI mTablet ECG	2023-07-28
US	K213730	MESI mTABLET TBI diagnostic system, MESI mTABLET TBI	2022-04-21
US	K201046	Automated ankle brachial pressure index measuring device, MESI mTABLET system	2020-12-11

MESI, DEVELOPMENT OF MEDICAL DEVICES, LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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