HomeGermanyCURASAN AG

CURASAN AG

Germany · Kleinostheim
✓ 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 7 registration records and 10 510(k), 10 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
5 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
6 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
11registrations
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 States7 registration records, 10 510(k), 10 PMA, 2 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: CURASAN AG

Company information

Country
Germany
City
Kleinostheim

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

12002
12003
12004
12007
12010
22011
12012
12016
12018

FDA listed device types

Filler, Bone Void, Calcium Compound 1Bone Grafting Material, Synthetic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK181721Ceracell Ortho Foam2018-09-17
USK160566Cerasorb Ortho Foam2016-12-02
USK111105CURASAN OSSEOLIVE DENTAL2012-12-20
CA101166OSSEOLIVE DENTAL BIOACTIVE POLYCRYSTALINE BONE GRAFT SUBSTITUTEClass III

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