HomeGermanyGEBR. BRASSELER GMBH & CO. KG

GEBR. BRASSELER GMBH & CO. KG

Germany · Lemgo
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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
50listed device types
Class I 31Class II 18Class III 0unclassified 1
plus 60 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
26registered devices
Class I 14Class II 12
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
4active device licences
Class II 2Class III 2
33 including historic records
TWTaiwanTFDA
19valid device licences
Class I 19
SGSingaporeHSA SMDR
19device registrations
CLASS B 19
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
56active ARTG entries
Class I 7IIa 48Class Is (sterile) 1
HKHong KongMDACS
11valid listings
Class II 11
ILIsraelAMAR
7registrations
RURussiaRoszdravnadzor
8active registrations
Class 1 1Class 2a 7
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 States60 registration records, 2 510(k), 0 PMA, 1 excluded
Brazil26 confirmed, 1 excluded
Saudi Arabia3 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: GEBR. BRASSELER GMBH & CO. KG · GEBR. BRASSELER GMBH & CO KG · Gebr. Brasseler GmbH & Co. KG

Company information

Country
Germany
City
Lemgo

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

12007 · K071352
12013 · K131264

FDA listed device types

showing 8 of 50
Post, Root Canal 1Template 1Handpiece, Air-Powered, Dental 1Point, Abrasive 1Accessories, Implant, Dental, Endosseous 1Drill, Dental, Intraoral 1Guide, Surgical, Instrument 1Point, Paper, Endodontic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK131264KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS2013-07-26
USK071352CERADRILL2007-06-29
BR10334210012PONTAS DIAMANTADAS KOMET-BRASSELERClass II
BR10334210011BROCAS DE CARBIDE KOMET-BRASSELERClass I
BR10356500056Instrumentais Cirúrgicos Estéreis em Aço Inoxidavel - Komet MedicalClass II
SAME0000000511SFDAA00014Naviflex Spreader
SAME0000000511SFDAA00015Separating strip
CA72637ROOT CANAL DRILLSClass II
CA72902ROOT POST (TITANIUM)Class III
CA72970ROOT POST CERAMICClass III

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