HomeUSAE.H. Medical Co.

E.H. Medical Co.

USA · San Diego
✓ 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
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class II 5
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
0active device licences
5 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 States1 registration records, 4 510(k), 0 PMA, 8,877 excluded
Brazil5 confirmed, 2,571 excluded
Saudi Arabia0 confirmed, 968 excluded
Canada0 confirmed, 1,237 excluded
Manufacturer names merged into this page: S.H. MEDICAL CORP. · C.H. MEDICAL LTD. · E- Medical.
Same-named companies — This database also contains companies with near-identical names: C.H. MEDICAL LTD., H & H Medical Corporation. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
San Diego

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

11981 · K811303
11985 · K850988
12005 · K051281
12014 · K133528

FDA listed device types

Camera, Television, Endoscopic, Without Audio 1

Registration details (sample)

MarketIdentifierNameClass / date
USK133528H&H EMERGENCY CRICOTHYROTOMY KIT2014-07-03
USK051281THE NEEDLE CATCHER2005-09-08
USK850988BOVO MOISTURE GUARD1985-04-16
BR80825010001DISPOSITIVO PARA ASPIRAÇÃO PLEURAL EASYVACClass II
BR80825010002VALVULA DE DRENAGEM PLEURAL TIPO HEIMLICHClass II
BR80825010003FRASCOS DE DRENAGEM PLEURAL COM SISTEMA EASYCONECTClass II

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