HomeCzechiaCIMPAX CZ s.r.o.

CIMPAX CZ s.r.o.

Czechia · Vyškov-Město · www.cimpax.com
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, United Kingdom, South Korea — 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
0UDI-DI device records
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class I 1Class IIa 1Class IIb 3
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
pendingnot queried
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, 0 510(k), 0 PMA, 2 excluded
United Kingdom5 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: CIMPAX CZ s.r.o.

Regulatory identity

UK responsible person
Eakin Surgical Ltd

Company information

Country
Czechia
Website
www.cimpax.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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 listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Catheter, Conduction, Anesthetic 1

Registration details (sample)

MarketIdentifierNameClass / date
UK47190CIMPAX® C-CAT Anaesthesia Catheter KitClass IIa
UK58039CIMPAX® Laparoscopic Hand Instuments Class IIb
UK61874CIMPAX® ELECTRODE LOOPClass IIb

Similar companies

EXATHERM s.r.o.
Czechia · markets 0
Synthesia Nitrocellulose, a.s.
Czechia · markets 3
ARIES a.s.
Czechia · markets 2
HTG Medical s.r.o.
Czechia · markets 1
KARDI AI Technologies s.r.o
Czechia · markets 0
Kettex Development s.r.o.
Czechia · markets 1
Is this your company? Claim the page, add information or report a data error.Claim / report an error →