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Home›Costa Rica›ESTABLISHMENT LABS S. A.

ESTABLISHMENT LABS S. A.

Costa Rica · Coyol Alajuela
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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
4listed device types
Class I 1Class II 0Class III 1unclassified 2
plus 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
17 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
5device registrations
CLASS B 2CLASS D 3
KRSouth KoreaMFDS GMP
4GMP quality-system certificates
Import 4
AUAustraliaTGA ARTG
6active ARTG entries
Class I 1Class III 3IIa 2
HKHong KongMDACS
5valid listings
Class II 2Class IV 3
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
3active registrations
Class 2b 1Class 3 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 States4 registration records, 0 510(k), 0 PMA, 1 excluded
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: ESTABLISHMENT LABS S.A. · ESTABLISHMENT LABS S.A. (BUILDING B15) · ESTABLISHMENT LABS BRASIL PRODUTOS PARA SAUDE LTDA · ESTABLISHMENT LABS S. A.
Same-named companies — This database also contains companies with near-identical names: ESTABLISHMENT LABS BRASIL PRODUTOS PARA SAUDE LTDA. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Costa Rica
City
Coyol Alajuela

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 listed device types

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled 1Tissue Expander And Accessories 1Mammary Sizer 1Expander, Surgical, Skin Graft 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80588390001Moldes Intraoperatórios para Prótese Mamária - EstérilClass II
BR80588399001Motiva Inflatable BalloonClass II
BR80588399003Motiva InjectorClass II

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