Home›USA›SUNRISE MEDICAL INTERNATIONAL INC.

SUNRISE MEDICAL INTERNATIONAL INC.

USA · Carmel

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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 5Class II 1Class III 0

plus 6 registration records and 33 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

25registered devices

Class I 11Class II 14

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

58registered 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 States6 registration records, 33 510(k), 0 PMA, 17 excluded

Brazil25 confirmed, 5 excluded

Saudi Arabia58 confirmed, 4 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SUNRISE MEDICAL INTERNATIONAL INC. · SUNRISE MEDICAL CO.,LTD, · SUNRISE MEDICAL · SUNRISE MEDICAL GMBH · Sunrise medical Gmbh & co · Sunrise medical GmbH

FDA 510(k) clearances by year

11992

11993

11994

11995

21997

71998

12000

22001

12002

12003

12004

32005

32006

32007

22008

12009

12010

12013

FDA listed device types

Connector, Airway (Extension) 1Clip, Nose 1Airway, Oropharyngeal, Anesthesiology 1Tubing, Pressure And Accessories 1Yoke Assembly, Medical Gas 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K123975	QUICKIE & ZIPPIE SERIES	2013-08-16
US	K093070	DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES	2010-01-26
US	K091919	DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST	2009-09-28
BR	82962139002	TORNEIRA DE 3 VIAS	Class II
BR	80990209001	EXTENSORES MULTIVIAS PARA CATETER Livre de DEHP	Class II
BR	80990209002	CONECTORES E CONEXÕES ENTERAIS	Class II
SA	ME0000008136SFDAA00003	Quickie	—
SA	ME0000008136SFDAA00026	Power Wheelchair	—

SUNRISE MEDICAL INTERNATIONAL 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