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Hospitech Respiration , Ltd.

Israel · Lod Central Il

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 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

5listed device types

Class I 2Class II 3Class III 0

plus 6 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class Im (measuring) 2

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 States6 registration records, 6 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: HOSPITECH RESPIRATION · HOSPITECH RESPIRATION LTD.

FDA 510(k) clearances by year

12010 · K093126

22013 · K131099

12016 · K150157

12018 · K180991

12022 · K221477

FDA listed device types

Apparatus, Suction, Ward Use, Portable, Ac-Powered 1Tube, Tracheal (W/Wo Connector) 1Cuff, Tracheal Tube, Inflatable 1Syringe, Irrigating (Non Dental) 1Dropper, Ether 1

Market	Identifier	Name	Class / date
US	K221477	AG100s	2022-12-29
US	K180991	AG 100s	2018-10-12
US	K150157	AnapnoGuard 100 Respiratory Guard System	2016-02-16
BR	80686369018	AG Cuffill	Class II

Hospitech Respiration , 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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