HomeCzech RepublicSpofaDental a.s.

SpofaDental a.s.

Czech Republic · Jicin Hradec Kralove
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Taiwan, Singapore, South Korea, Israel, Russia — 6 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
13listed device types
Class I 8Class II 4Class III 0unclassified 1
plus 23 registration records and 0 510(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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
6active registrations
Class 1 1Class 2a 5
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 States23 registration records, 0 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: SpofaDental a.s.

Company information

Country
Czech Republic
City
Jicin Hradec Kralove

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

showing 8 of 13
Wrap, Sterilization 1Indicator, Physical/Chemical Sterilization Process 1Material, Impression 1Cement, Dental 1Instruments, Dental Hand 1Wax, Dental, Intraoral 1Disk, Abrasive 1Clamp, Rubber Dam 1

Similar companies

ADM, a.s.
Czech Republic · markets 2
ALP ECOLOGY S.R.O.
Czech Republic · markets 2
Arrow International C.R. a.s.
Czech Republic · markets 4
AVEFLOR
Czech Republic · markets 1
BEAUTYXPORT S.R.O.
Czech Republic · markets 1
BMT MEDICAL TECHNOLOGY S.R.O.
Czech Republic · markets 3
Is this your company? Claim the page, add information or report a data error.Claim / report an error →