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Circadiance, LLC

USA · Export

✓ Record-verifiedregistrations found in 5 markets

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

5listed device types

Class I 1Class II 4Class III 0

plus 11 registration records and 5 510(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

11active device licences

Class II 9Class III 2

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States11 registration records, 5 510(k), 0 PMA

Canada11 confirmed, 0 excluded

Manufacturer names merged into this page: CIRCADIANCE · CIRCADIANCE LLC

FDA 510(k) clearances by year

12009 · K092362

12012 · K120757

12013 · K130481

12016 · K151683

12017 · K162905

FDA listed device types

Monitor, Apnea, Facility Use 1Ventilator, Non-Continuous (Respirator) 1Monitor, Apnea, Home Use 1Oximeter 1Mask, Oxygen 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K162905	SleepWeaver 3D Nasal Mask	2017-03-15
US	K151683	SleepWeaver Advance Pediatric Nasal CPAP Mask	2016-04-05
US	K130481	SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK	2013-05-24
CA	15721	SMARTMONITOR 2	Class II
CA	76360	SMARTMONITOR	Class III
CA	76643	SMARTMONITOR 2PSL (PROFESSIONAL SERIES LIGHT) WITH MODEM	Class III

Circadiance, LLC

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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