HomeBulgariaSMART SOFT HEALTHCARE

SMART SOFT HEALTHCARE

Bulgaria · Varna
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, South Korea, 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
1listed device types
Class I 0Class II 1Class III 0
plus 2 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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
IIa 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 States2 registration records, 4 510(k), 0 PMA, 17 excluded
Brazil0 confirmed, 4 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: SMART SOFT HEALTHCARE

Company information

Country
Bulgaria
City
Varna

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

12022 · K220497
12024 · K241211
12025 · K250367
12026 · K254015

FDA listed device types

Automated Radiological Image Processing Software 1

Registration details (sample)

MarketIdentifierNameClass / date
USK254015CoLumbo C-Spine2026-04-01
USK250367CoLumboX2025-05-28
USK241211CoLumbo2024-08-15

Similar companies

AICHHORN AND CO EOOD
Bulgaria · markets 1
Kre Pharmaplast EOOD
Bulgaria · markets 0
WHL GERMANIA LTD
Bulgaria · markets 0
Apyx Bulgaria Ltd.
Bulgaria · markets 2
BTL Industries JSC
Bulgaria · markets 5
Cocoon Medical International, Ltd
Bulgaria · markets 2
Is this your company? Claim the page, add information or report a data error.Claim / report an error →