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AirStrip Technologies, Inc.

USA · San Antonio

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, 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 0Class II 5Class III 0

plus 9 registration records and 15 510(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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

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 States9 registration records, 15 510(k), 0 PMA

Manufacturer names merged into this page: AirStrip Technologies, Inc. · AIRSTRIP TECHNOLOGIES, INC.

FDA 510(k) clearances by year

22009

12010

22011

32012

12013

22014

12015

12016

12018

12021

FDA listed device types

System, Network And Communication, Physiological Monitors 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Medium-Term Adjunctive Predictive Cardiovascular Indicator 1System, Monitoring, Perinatal 1Adjunctive Hemodynamic Indicator With Decision Point 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K211949	AirStrip ONE Web Client with Alarm Communication Management (ACM)	2021-12-09
US	K182226	AirStrip RPM InvisionHeart Adapter	2018-09-11
US	K160862	AirStrip RPM	2016-09-19

AirStrip Technologies, Inc.

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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