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Somnetics International, Inc. (Dba Transcend Inc)

USA · Fridley

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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 2Class II 2Class III 0

plus 6 registration records and 4 510(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

6active device licences

Class II 6

7 including historic records

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 States6 registration records, 4 510(k), 0 PMA

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: SOMNETICS INTERNATIONAL, INC · SOMNETICS INTERNATIONAL, INC.

FDA 510(k) clearances by year

22013 · K132127

12018 · K180388

12026 · K252338

FDA listed device types

Humidifier, Respiratory Gas, (Direct Patient Interface) 1Ventilator, Non-Continuous (Respirator) 1Condenser, Heat And Moisture (Artificial Nose) 1Tubing, Pressure And Accessories 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252338	MySleepDash	2026-04-17
US	K180388	Transcend 365 miniCPAP System	2018-11-30
US	K132127	TRANSCEND AUTO	2013-10-17
CA	87415	TRANSCEND SLEEP APNEA THERAPY SYSTEM	Class II
CA	91582	TRANSCEND HEATED HUMIDIFIER	Class II
CA	91622	TRANSCEND AUTO SLEEP APNEA THERAPY SYSTEM	Class II

Somnetics International, Inc. (Dba Transcend 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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