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ADROIT MEDICAL SYSTEMS, INC.

USA · Loudon

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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 1Class II 4Class III 0

plus 8 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 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

1active device licences

Class II 1

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States8 registration records, 6 510(k), 0 PMA, 2 excluded

Brazil2 confirmed, 0 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ADROIT MEDICAL SYSTEMS, INC. · ADROIT MEDICAL SYSTEMS INC. · Adroit Medical Systems, Inc.

FDA 510(k) clearances by year

21992 · K921920

21997 · K970197

11998 · K973981

12008 · K073712

FDA listed device types

Pack, Hot Or Cold, Water Circulating 1Transducer, Ultrasonic, Diagnostic 1System, Thermal Regulating 1Drape, Surgical, Exempt 1Gown, Examination 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K073712	SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100	2008-06-06
US	K973981	SAFEPASS STERILIZATION POUCH	1998-01-29
US	K970197	HTP-1500 LOCALIZED HEAT THERAPY PUMP	1997-09-10
BR	10171610064	Colchões de Aquecimento/Resfriamento por Condução - Reutilizável	Class I
BR	10171610061	Cobertores de Aquecimento por Condução.	Class I
CA	88509	SOFT-TEMP	Class II

ADROIT MEDICAL SYSTEMS, 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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