HomeGermanyOSARTIS GMBH

OSARTIS GMBH

Germany · Munster
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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
9listed device types
Class I 3Class II 5Class III 0unclassified 1
plus 17 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
7 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
6 including historic records
TWTaiwanTFDA
6valid device licences
Class II 6
SGSingaporeHSA SMDR
1device registrations
D WITH MEDICINAL PRODUCT 1
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
9active ARTG entries
Class I 2Class III 3IIa 1IIb 3
HKHong KongMDACS
3valid listings
Class III 2Class IV 1
ILIsraelAMAR
3registrations
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 States17 registration records, 6 510(k), 0 PMA
Manufacturer names merged into this page: OSARTIS GMBH

Company information

Country
Germany
City
Munster

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

22019 · K192394
32021 · K202458
12024 · K240856

FDA listed device types

showing 8 of 9
Dispenser, Cement 1Evacuator, Vapor, Cement Monomer 1Mixer, Cement, For Clinical Use 1Bone Cement, Antibiotic 1Bone Cement, Posterior Screw Augmentation 1Thoracolumbosacral Pedicle Screw System 1Bone Cement 1Cement, Bone, Vertebroplasty 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds2024-11-20
USK202458BonOs Inject, Pedicle screw kits, Cement pusher2021-05-18
USK210125BonOs HV Genta, BonOs MV Genta, BonOs LV Genta2021-03-19

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