HomeFranceDIAGAST

DIAGAST

France · Loos
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Hong Kong, Israel, Russia — 9 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 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
12registered devices
Class I 9Class II 3
13 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
19 including historic records
TWTaiwanTFDA
12valid device licences
Class I 1Class II 11
SGSingaporeHSA SMDR
10device registrations
CLASS C 1CLASS D 9
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
6valid listings
IVD C 1IVD D 5
ILIsraelAMAR
8registrations
RURussiaRoszdravnadzor
25active registrations
Class 2b 2Class 3 23
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 States4 registration records, 0 510(k), 0 PMA
Brazil12 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: DIAGAST

Company information

Country
France
City
Loos

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 listed device types

Media, Potentiating For In Vitro Diagnostic Use 1Solution, Stabilized Enzyme 1Kit, Quality Control For Blood Banking Reagents 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10234400230FREELYS READERClass II
BR10234400231QWALYSClass II
BR10234400235MagneLysClass I
CA35658RED BLOOD CELL PANELSClass III

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