HomeCanadaEci Medical Technologies, Inc.

Eci Medical Technologies, Inc.

Canada · Bridgewater
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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
9510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
3active device licences
Class II 3
4 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, 9 510(k), 0 PMA
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: ECI MEDICAL TECHNOLOGIES INC.

Company information

Country
Canada
City
Bridgewater

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

41995 · K954535
11997 · K970015
11998 · K971471
11999 · K984337
22002 · K021598

Registration details (sample)

MarketIdentifierNameClass / date
USK021598ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE2002-06-10
USK020918ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE2002-04-19
USK984337ELASTYLON POWDER-FREE SURGICAL GLOVE1999-04-09
CA2704ELASTYREN NON-STERILE SYNTHETIC MEDICAL GLOVESClass II
CA2705ELASTYREN LATEX-FREE STERILE SURGICAL GLOVESClass II
CA5865ELASTYREN POWDER-FREE NON-STERILE MEDICAL GLOVESClass II

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