HomeGermanyEVONOS GMBH & CO. KG

EVONOS GMBH & CO. KG

Germany · Tuttlingen
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel — 7 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
64listed device types
Class I 60Class II 4Class III 0
plus 64 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
11registered devices
Class I 4Class II 7
29 including historic records
SASaudi ArabiaSFDA
17registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
12 including historic records
TWTaiwanTFDA
12valid device licences
Class I 11Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
Class I 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
13registrations
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 States64 registration records, 1 510(k), 0 PMA
Brazil11 confirmed, 0 excluded
Saudi Arabia17 confirmed, 0 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: EVONOS GMBH & CO. KG · EVONOS GMBH & CO.KG · evonos GmbH & Co. KG · evonos GmbH & Co.KG

Company information

Country
Germany
City
Tuttlingen

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

12024 · K231403

FDA listed device types

showing 8 of 64
Forceps 1Instrument, Ent Manual Surgical 1Rasp 1Chisel, Surgical, Manual 1Perforator, Ear-Lobe 1Saw, Nasal 1Handle, Scalpel 1Transilluminator, Fiber Optic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231403evoDrill Cranial Perforator2024-03-06
BR80003890167Sistema de Fixação Óssea EvonosClass I
BR10099439027Sistema de apoio de cabeça evoBaseClass II
BR80003890152Pinça fórceps para aplicação e remoção de clipes hemostáticosClass I
SAME0000002540SFDAA00003Loop, acc. to Billeau, straight
SAME0000002540SFDAA00004Ear scissors, acc. to Bellucci, micro, straight, size 80
CA83017STAINLESS STEEL BURRSClass II
CA83021DIAMOND BURRSClass II
CA96487TROCAR ENTClass II

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