HomeUSASHEATHING TECHNOLOGIES, INC.

SHEATHING TECHNOLOGIES, INC.

USA · Morgan Hill
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, 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
6listed device types
Class I 0Class II 6Class III 0
plus 11 registration records and 7 510(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
11 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
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 States11 registration records, 7 510(k), 0 PMA
Manufacturer names merged into this page: SHEATHING TECHNOLOGIES, INC.

Company information

Country
USA
City
Morgan Hill

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

11999
12005
12009
12010
12012
12013
12016

FDA listed device types

Transducer, Ultrasonic, Diagnostic 1Radiology-Diagnostic Kit 1Biopsy Needle Guide Kit 1Colonoscope And Accessories, Flexible/Rigid 1Endoscopic Contamination Prevention Sheath 1Media, Coupling, Ultrasound 1

Registration details (sample)

MarketIdentifierNameClass / date
USK153212Sheathes Ultrasound Probe Covers2016-03-04
USK130041SHEATHES STERILE ULTRASOUND GEL2013-02-06
USK112827SHEATHES ULTRASOND GEL2012-06-22

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