Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›France›Hpi, Inc.

Hpi, Inc.

France · Newton Centre
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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
6510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 4
5 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
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, 6 510(k), 0 PMA
Brazil4 confirmed, 1 excluded
Manufacturer names merged into this page: HPI

Company information

Country
France
City
Newton Centre

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

21990 · K905086
21991 · K910383
11992 · K915086
11993 · K922116

Registration details (sample)

MarketIdentifierNameClass / date
USK922116POWDER FREE NITRILE GLOVE1993-02-08
USK915086HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES1992-06-17
USK910383HPI SENSI-SHIELD GLOVE KIT1991-03-20
BR80105980016Kit Instrumental CAPClass I
BR80105980017Kit Instrumental REEDClass I
BR80105980018Kit Instrumental MORPHOClass I

Similar companies

@bloc SAS
France · markets 0
A. Legrand SAS
France · markets 0
Acime Frame SAS
France · markets 5
ADDEV Materials SAS
France · markets 1
ADHEX TECHNOLOGIES SAS
France · markets 5
Advanced Silicone Coating SAS
France · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →