HomeAustriaKlema Dentalprodukte GMBH

Klema Dentalprodukte GMBH

Austria · Meiningen
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Israel, Russia — 7 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
4listed device types
Class I 0Class II 4Class III 0
plus 13 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
9registered devices
Class II 9
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
4active device licences
Class III 4
6 including historic records
TWTaiwanTFDA
6valid device licences
Class II 6
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 States13 registration records, 0 510(k), 0 PMA
Brazil9 confirmed, 1 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: Klema Dentalprodukte GMBH · KLEMA DENTALPRODUKTE GMBH

Company information

Country
Austria
City
Meiningen

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

Denture, Plastic, Teeth 1Agent, Tooth Bonding, Resin 1Teeth, Porcelain 1Powder, Porcelain 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10336460023PORCELANA CREATIONClass II
BR10336460114PORCELANA CREATION: WILLI GELLER CREATIONClass II
BR80384720047Creation LSClass II
CA77214CREATION AV DENTAL PORCELAIN SYSTEMClass III
CA77215CREATION CP DENTAL PORCELAINClass III
CA77218CREATION LF DENTAL PORCELAIN SYSTEMClass III

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