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 comparableCNChinaNMPA
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.
Australia, Hong Kong, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
How these numbers were verified
record-verifiedCompany-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.
Company information
- Country
- Slovenia
- City
- Ljubljana
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
FDA 510(k) clearances by year
12018 · K172655
12020 · K201046
12022 · K213730
12023 · K223670
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 |
Signed in · open all 10 sampled records for this company and export → · Export rows left this month —/100