Home›USA›SAFEGUARD US OPERATING, LLC.

SAFEGUARD US OPERATING, LLC.

USA · Huntersville

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, 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

34listed device types

Class I 22Class II 11Class III 0unclassified 1

plus 33 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 3Class II 2

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

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 States33 registration records, 0 510(k), 0 PMA, 3 excluded

Brazil5 confirmed, 1 excluded

Manufacturer names merged into this page: SAFEGUARD US OPERATING, LLC · SAFEGUARD US OPERATING, LLC.

FDA listed device types

showing 8 of 34

Catheter Introducer Kit 1Body Fluid Clean Up Kit 1Tube Tracheostomy And Tube Cuff 1I.V. Start Kit 1Warmer, Blood, Non-Electromagnetic Radiation 1Intravenous Extension Tubing Set 1Warmer, Thermal, Infusion Fluid 1Ventilator, Emergency, Powered (Resuscitator) 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80469670028	Bandagem para Compressão Battle Wrap	Class I
BR	80469670029	Bandagem para Compressão Battle Bandage	Class I
BR	80469679008	Kit Para Cricotireoidostomia de Emergência	Class II

SAFEGUARD US OPERATING, LLC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies