HomeCzech RepublicCOMPEX, spol. s r.o.

COMPEX, spol. s r.o.

Czech Republic · Brno
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 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 0Class II 2Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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 States3 registration records, 2 510(k), 0 PMA, 2 excluded
Brazil2 confirmed, 0 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: COMPEX, spol. s r.o. · COMPEX, SPOL. S R.O. · COMPEX SPOL. S.R.O

Company information

Country
Czech Republic
City
Brno

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

12023 · K213247
12025 · K240311

FDA listed device types

Low Power Electrosurgical Devices For Skin Lesion Destruction 1Electrosurgical, Cutting & Coagulation & Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240311JETT Medical II2025-01-22
USK213247JETT PLASMA Medical II2023-03-14
BR80827009004Jett Plasma LiftClass II
BR80827009001Jett Plasma for HerClass II

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