HomeUSASunrise Medical (Us), LLC

Sunrise Medical (Us), LLC

USA · Mount Juliet
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, 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
21listed device types
Class I 19Class II 2Class III 0
plus 70 registration records and 38 510(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
64registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
4valid device licences
Class I 4
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 States70 registration records, 38 510(k), 0 PMA, 15 excluded
Brazil25 confirmed, 5 excluded
Saudi Arabia64 confirmed, 3 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: Sunrise Medical (US) LLC · SUNRISE MEDICAL (US) LLC · SUNRISE MEDICAL CO.,LTD, · SUNRISE MEDICAL · SUNRISE MEDICAL GMBH · Sunrise medical Gmbh & co
Same-named companies — This database also contains companies with near-identical names: sunrise medical sl. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Mount Juliet

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11994
11995
21997
71998
12000
22001
12002
12003
12004
32005
32006
32007
22008
12009
12010
12013
22014
12016
12018
12022

FDA listed device types

showing 8 of 21
Cushion, Flotation 1Armrest, Wheelchair 1Device, Anti-Tip, Wheelchair 1Footrest, Wheelchair 1Aid, Transfer 1Components, Wheelchair 1Belt, Wheelchair 1Walker, Mechanical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220213Empulse R902022-03-30
USK172384Quickie(r) Q700-UP M2018-01-16
USK160031Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)2016-07-14
BR82962139002TORNEIRA DE 3 VIASClass II
BR80990209001EXTENSORES MULTIVIAS PARA CATETER Livre de DEHPClass II
BR80990209002CONECTORES E CONEXÕES ENTERAISClass II
SAME0000008136SFDAA00003Quickie
SAME0000008136SFDAA00026Power Wheelchair

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