HomeUSASONTEC INSTRUMENTS, INC.

SONTEC INSTRUMENTS, INC.

USA · Centennial
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, Israel — 3 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
210listed device types
Class I 194Class II 16Class III 0
plus 222 registration records and 1 510(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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States222 registration records, 1 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: SONTEC INSTRUMENTS, INC.

Company information

Country
USA
City
Centennial

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

12016 · K152400

FDA listed device types

showing 8 of 210
Chisel, Surgical, Manual 1Knife, Nasal 1Driver, Surgical, Pin 1Tamp 1Sound, Urethral, Metal Or Plastic 1Spud, Ophthalmic 1Headlamp, Operating, Battery-Operated 1Fork, Tuning 1

Registration details (sample)

MarketIdentifierNameClass / date
USK152400General & Plastic Surgery Instruments2016-01-22

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