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ZIBO SUNRISE MEDICAL CO., LTD

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Israel — 4 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

33510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 33 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

31registered devices

Class I 11Class II 20

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

SASaudi ArabiaSFDA

59registered 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

2registrations

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 States0 registration records, 33 510(k), 0 PMA, 18 excluded

Brazil31 confirmed, 4 excluded

Saudi Arabia59 confirmed, 3 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SUNRISE MEDICAL CO.,LTD, · ZIBO SUNRISE MEDICAL CO., LTD · SUNRISE MEDICAL · SUNRISE MEDICAL GMBH · Zibo Sunrise Medical Co., Ltd · Sunrise medical Gmbh & co

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	ME0000002276SFDAA00002	Warming Blanket	—
SA	ME0000008136SFDAA00003	Quickie	—

ZIBO SUNRISE MEDICAL CO., LTD

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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