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REVMEDX, INC.

USA · Wilsonville

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, 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

4listed device types

Class I 3Class II 1Class III 0

plus 7 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

1active device licences

Class II 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States7 registration records, 7 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: REVMEDX, INC.

FDA 510(k) clearances by year

12014

12015

12016

12017

12018

12021

12025

FDA listed device types

Dressing, Compression 1Gauze / Sponge,Nonresorbable For External Use 1Tourniquet, Nonpneumatic 1Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use 1

Market	Identifier	Name	Class / date
US	K253290	XSTAT P15	2025-11-12
US	K210676	XSTAT 30 Pouch	2021-08-27
US	K180051	XSTAT 30, 1-Pack	2018-05-18
CA	96938	XSTAT	Class II

REVMEDX, 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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