HomeUSAEsco Medical

Esco Medical

USA · Stony Brook
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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
3listed device types
Class I 0Class II 3Class III 0
plus 3 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 1Class II 3
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 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 States3 registration records, 1 510(k), 0 PMA, 3 excluded
Brazil4 confirmed, 3 excluded
Saudi Arabia4 confirmed, 0 excluded
Manufacturer names merged into this page: Esco Medical Technologies, UAB · ESCO MEDICAL INSTRUMENTS, INC. · ESCO MEDICAL TECHNOLOGIES, UAB · ESCO MEDICAL TECHNOLOGIES, LTD. · NINGBO HAISHU ESCO MEDICAL TECHNOLOGY CO., LTD.

Company information

Country
USA
City
Stony Brook

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

11994 · K931323

FDA listed device types

Accessory, Assisted Reproduction, Exempt 1Accessory, Assisted Reproduction 1Labware, Assisted Reproduction 1

Registration details (sample)

MarketIdentifierNameClass / date
USK931323MOUNTABLE KNIFE1994-04-28
BR10330719037Família de Incubadoras Miri® e Mini Miri®Class II
BR10330719038Incubadora Time-Lapse Miri® TL-6 e TL-12Class II
BR10330710135Workstation para Reprodução AssistidaClass I
SAME0000018290SFDAA00003Ultrasonic Cleaner
SAME0000018290SFDAA00006Dental Sealing Machine

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