HomeUSAAltimate Medical, Inc.

Altimate Medical, Inc.

USA · Burnet
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 7 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
20listed device types
Class I 19Class II 1Class III 0
plus 23 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
5registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
13active ARTG entries
Class I 13
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 1 2
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 States23 registration records, 2 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Saudi Arabia5 confirmed, 0 excluded
Manufacturer names merged into this page: Altimate Medical, Inc. · ALTIMATE MEDICAL, INC. · ALTIMATE MEDICAL INC.

Company information

Country
USA
City
Burnet

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

12009 · K091242
12013 · K123834

FDA listed device types

showing 8 of 20
Exerciser, Non-Measuring 1Table, Mechanical 1Chair, Adjustable, Mechanical 1Aid, Transfer 1Table, Powered 1Chair, With Casters 1Adaptor, Dressing 1Device, Pressure Applying 1

Registration details (sample)

MarketIdentifierNameClass / date
USK123834EASYSTAND BANTAM MEDIUM2013-08-13
USK091242BANTAM2009-07-06
BR80026710017APARELHOS ORTOPÉDICOS EASYSTANDClass I
SAME0000008551SFDAA00003easy stand glider
SAME0000008551SFDAA00002EasyStand Bantam Medium

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