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A-M Systems, Inc.

USA · Sequim

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, 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

13listed device types

Class I 12Class II 1Class III 0

plus 16 registration records and 3 510(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

3active device licences

Class II 3

12 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States16 registration records, 3 510(k), 0 PMA, 1,626 excluded

Brazil0 confirmed, 179 excluded

Saudi Arabia0 confirmed, 47 excluded

Canada3 confirmed, 245 excluded

Manufacturer names merged into this page: A-M Systems · A-M SYSTEMS, LLC

FDA 510(k) clearances by year

12000 · K000654

12007 · K063526

12013 · K130664

FDA listed device types

showing 8 of 13

Calibrator, Volume, Gas 1Mouthpiece, Breathing 1Flowmeter, Tube, Thorpe, Back-Pressure Compensated 1Absorber, Carbon-Dioxide 1Pump, Nebulizer, Manual 1Connector, Airway (Extension) 1Cannula, Nasal, Oxygen 1Mask, Oxygen 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130664	HYRDROMAX HMEF	2013-06-21
US	K063526	A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER	2007-06-29
US	K000654	VBMAX	2000-11-14
CA	73327	PULMONARY/RESPIRATORY FUNCTION TEST ANALYZER - ABSORBER COLUMN	Class II
CA	74167	LEVERHALER	Class II
CA	104435	BAG, BREATHING, LATEX FREE	Class II

A-M 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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