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Home›USA›ENDOSCOPIC TECHNOLOGIES, INC. DBA ESTECH, INC

ENDOSCOPIC TECHNOLOGIES, INC. DBA ESTECH, INC

USA · San Ramon
✓ 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
5510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
8registered devices
Class I 8
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
6active device licences
Class II 6
10 including historic records
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, 5 510(k), 0 PMA, 1 excluded
Brazil8 confirmed, 0 excluded
Canada6 confirmed, 0 excluded
Manufacturer names merged into this page: ENDOSCOPIC TECHNOLOGIES, INC. DBA ESTECH, INC · ENDOSCOPIC TECHNOLOGIES, INC. DBA: ESTECH
Same-named companies — This database also contains companies with near-identical names: Endoscopic Technologies, Inc. D/B/A Estech. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
San Ramon

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

22009 · K091542
12010 · K100224
12011 · K110913
12012 · K113475

Registration details (sample)

MarketIdentifierNameClass / date
USK113475ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM2012-03-20
USK110913ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY2011-09-23
USK100224ESTECH COBRA BIPOLSR II2010-04-07
BR80050969001PEGADOR DE SUTURA - ESTECHClass I
BR80050960055EMPRURRADOR DE NÓ LIVClass I
BR80050960052TESOURA CIRÚRGICA ESTECHClass I
CA76707OPVAC SYNERGYClass II
CA76737BLOW MISTERClass II
CA76738HEART POSITIONERSClass II

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