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Equashield Medical , Ltd.

Israel · Tefen

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel — 5 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

4listed device types

Class I 3Class II 1Class III 0

plus 12 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

1 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States12 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: EQUASHIELD MEDICAL LTD · EQUASHIELD MEDICAL LTD.

FDA 510(k) clearances by year

12010 · K101940

12014 · K132899

12015 · K150219

12017 · K170706

12023 · K221513

FDA listed device types

Administration Set Securement Device 1Tube, Tissue Culture 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221513	Equashield Closed System Transfer Device	2023-02-17
US	K170706	Equashield Closed System drug Transfer Device (CSTD)	2017-07-03
US	K150219	Equashield Closed System drug Transfer Device (CSTD)	2015-11-05
BR	81789470001	EQUASHIELD Dispositivo de Transferência de Substâncias em Sistema Fe	Class I

Equashield Medical , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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