HomeIrelandORTHOXEL

ORTHOXEL

Ireland · Cork Cork
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Singapore — 2 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
11listed device types
Class I 8Class II 3Class III 0
plus 11 registration records and 2 510(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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States11 registration records, 2 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: ORTHOXEL

Company information

Country
Ireland
City
Cork Cork

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

12017 · K170972
12018 · K181375

FDA listed device types

showing 8 of 11
Screwdriver 1Reamer 1Wrench 1Bit, Drill 1Gauge, Depth 1Passer, Wire, Orthopedic 1Awl 1Orthopedic Manual Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK181375Apex Femoral Nailing System2018-07-17
USK170972Apex Tibial Nailing System2017-12-20

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