HomeSwitzerlandKeri Medical SA

Keri Medical SA

Switzerland · Plan-Les-Ouates Geneve
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Australia, Hong Kong, 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
9listed device types
Class I 7Class II 1Class III 1
plus 9 registration records and 1 510(k), 7 PMA
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
Class I 1IIb 3
HKHong KongMDACS
2valid listings
Class III 2
ILIsraelAMAR
6registrations
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 States9 registration records, 1 510(k), 7 PMA
Manufacturer names merged into this page: KERI MEDICAL

Company information

Country
Switzerland
City
Plan-Les-Ouates Geneve

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

12022 · K211385

FDA listed device types

showing 8 of 9
Starter, Bone Screw 1Rasp, Surgical, General & Plastic Surgery 1Tray, Surgical 1Passer, Wire, Orthopedic 1Awl 1Tray, Surgical, Instrument 1Orthopedic Manual Surgical Instrument 1Prosthesis, Finger, Constrained, Polymer 1

Registration details (sample)

MarketIdentifierNameClass / date
USK211385KeriFlex® MCP and PIP Finger Joint Prostheses2022-07-27

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