Home›USA›Prosomnus Sleep Technologies, Inc.

Prosomnus Sleep Technologies, Inc.

USA · Pleasanton

✓ 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

6listed device types

Class I 1Class II 5Class III 0

plus 7 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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 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 States7 registration records, 3 510(k), 0 PMA

Manufacturer names merged into this page: PROSOMNUS SLEEP TECHNOLOGIES

FDA 510(k) clearances by year

12020 · K202529

12022 · K221889

12026 · K252765

FDA listed device types

Sleep Appliances With Patient Monitoring 1Device, Anti-Snoring 1Oximeter, Wellness 1Oximeter 1Device, Jaw Repositioning 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252765	ProSomnus RPMO2 OSA Device (RPMO2 OSA)	2026-04-06
US	K221889	ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring	2022-10-06
US	K202529	ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring	2020-11-20

Prosomnus Sleep 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)

Similar companies