HomeGermanyCERAMTEC GmbH Medical Products Division

CERAMTEC GmbH Medical Products Division

Germany · Marktredwitz Bavaria
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, South Korea — 2 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
16listed device types
Class I 0Class II 14Class III 2
plus 107 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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
9GMP quality-system certificates
Import 8Manufacturing 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 States107 registration records, 0 510(k), 0 PMA, 2 excluded
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: CERAMTEC GmbH Medical Products Division

Company information

Country
Germany
City
Marktredwitz Bavaria

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 16
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented 1Wire, Surgical 1Prosthesis, Hip, Hemi-, Femoral, Metal Ball 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Screw, Fixation, Bone 1Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented 1

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