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Atmos, Inc.

USA · Exton

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

14listed device types

Class I 10Class II 4Class III 0

plus 17 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

0active device licences

TWTaiwanTFDA

pendingnot queried

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 States17 registration records, 3 510(k), 0 PMA, 2 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ATMOS INC.

FDA 510(k) clearances by year

22009 · K090130

12011 · K103042

FDA listed device types

showing 8 of 14

Laryngoscope, Nasopharyngoscope 1Nasopharyngoscope (Flexible Or Rigid) 1Colposcope (And Colpomicroscope), Exempt 1Pump, Portable, Aspiration (Manual Or Powered) 1Chair, Surgical, Ac-Powered 1Stimulator, Caloric-Water 1Stimulator, Caloric-Air 1Source, Carrier, Fiberoptic Light 1

Market	Identifier	Name	Class / date
US	K103042	ATMOS E 201 THORAX AND ATMOS S 201 THORAX	2011-04-15
US	K090130	ATMOS S041 WOUND	2009-04-02
US	K090445	ATMOS C361/C451 SUCTION PUMP	2009-02-27

Atmos, 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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