HomeBrazilGERATHERM MEDICAL LATIN AMERICA LTDA.

GERATHERM MEDICAL LATIN AMERICA LTDA.

Brazil
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
20registered devices
Class I 1Class II 19
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
13active device licences
Class II 13
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 States0 registration records, 2 510(k), 0 PMA, 1 excluded
Brazil20 confirmed, 2 excluded
Canada13 confirmed, 0 excluded
Manufacturer names merged into this page: GERATHERM MEDICAL AG · GERATHERM MEDICAL LATIN AMERICA LTDA.
Same-named companies — This database also contains companies with near-identical names: Geratherm Medical AG. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Brazil

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

22010 · K093244

Registration details (sample)

MarketIdentifierNameClass / date
USK093244UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX2010-10-19
USK093694GERATHERM UNIQUERESC2010-09-20
BR80200260016TERMÔMETRO DIGITAL MEDEQCOClass II
BR80200269011Medidor de Pressão Arterial de BraçoClass II
BR80200269012Oximetro de PulsoClass II
CA87082GERATHERM DATA THERM II CONTINUOUS TEMPERATURE MONITORClass II
CA87083UNIQUERESC+ PATIENT WARMING SYSTEMClass II
CA87084UNIQUETEMP PATIENT WARMING SYSTEMClass II

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