HomeGermanyOT MEDICAL GMBH

OT MEDICAL GMBH

Germany · Bremen
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Russia — 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
8listed device types
Class I 6Class II 2Class III 0
plus 9 registration records and 4 510(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
3 including historic records
TWTaiwanTFDA
7valid device licences
Class I 3Class III 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2a 1Class 2b 1
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 States9 registration records, 4 510(k), 0 PMA
Manufacturer names merged into this page: OT MEDICAL GMBH

Company information

Country
Germany
City
Bremen

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

12012 · K113113
12014 · K141550
12015 · K151432
12016 · K151608

FDA listed device types

Bur, Dental 1Punch, Biopsy, Surgical 1Accessories, Implant, Dental, Endosseous 1Handle, Instrument, Dental 1Gauge, Depth, Instrument, Dental 1Chisel, Osteotome, Surgical 1Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK1516084plus6Line Abutment System2016-04-13
USK151432NaturalLine Abutment2015-11-05
USK141550INSTAFIX SHAPE MEMORY FIXATION SYSTEM2014-07-11

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