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Home›CMR SURGICAL BRASIL IMPORTACAO E COMERCIO DE EQUIPAMENTOS MEDICOS LTDA

CMR SURGICAL BRASIL IMPORTACAO E COMERCIO DE EQUIPAMENTOS MEDICOS LTDA

✓ 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
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
8 including historic records
SASaudi ArabiaSFDA
6registered 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 States1 registration records, 2 510(k), 0 PMA, 1 excluded
Brazil2 confirmed, 0 excluded
Saudi Arabia6 confirmed, 0 excluded
Manufacturer names merged into this page: CMR SURGICAL LIMITED · CMR SURGICAL LTD. · CMR SURGICAL BRASIL IMPORTACAO E COMERCIO DE EQUIPAMENTOS MEDICOS LTDA · CMR Surgical Ltd
Same-named companies — This database also contains companies with near-identical names: CMR SURGICAL LIMITED. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

12024 · DEN230078
12025 · K252111

FDA listed device types

Modular Electromechanical Surgical System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252111Versius Surgical System (Versius Plus)2025-12-16
USDEN230078Versius Surgical System2024-10-11
BR8241245900290908 - Endoscópio Versius 0°. 90907 - Endoscópio Versius 30°Class II
BR82412459001Instrumentais VersiusClass II
SAME0000022088SFDAA00022Monopolar Instrument Cable—
SAME0000022088SFDAA00024Bedside Unit Cable—

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