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Home›USA›Diagnostica Stago, Incorporated

Diagnostica Stago, Incorporated

USA · Asnieres Sur Seine
✓ 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
33listed device types
Class I 7Class II 25Class III 0unclassified 1
plus 241 registration records and 24 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
75registered devices
Class I 1Class II 74
90 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
10active device licences
Class II 10
40 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 States241 registration records, 24 510(k), 0 PMA, 1 excluded
Brazil75 confirmed, 1 excluded
Canada10 confirmed, 0 excluded
Manufacturer names merged into this page: Diagnostica Stago - Taverny · DIAGNOSTICA STAGO, INC. · Diagnostica Stago - Gennevilliers · DIAGNOSTICA STAGO SAS · DIAGNOSTICA STAGO S.A.S · DIAGNOSTICA STAGO S.A.S.
Same-named companies — This database also contains companies with near-identical names: DIAGNOSTICA STAGO S.A.S.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Asnieres Sur Seine

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

52001
32006
22008
42009
12010
12011
22013
12014
12015
12016
12022
12023
12026

FDA listed device types

showing 8 of 33
Antithrombin Iii Quantitation 1Test, Thrombin Time 1Calibrator, Secondary 1Calibrator, Primary 1Assay, Heparin 1Instrument, Coagulation, Automated 1Reagent & Control, Partial Thromboplastin Time 1Plasma, Control, Normal 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253658STA Satellite Max®2026-04-27
USK212183STA R Max 3, STA Compact Max 32023-06-07
USK211485STA- NeoPTimal2022-12-23
BR81457600071FAMILIA STA® RIVAROXABANClass II
BR81457600072FAMÍLIA STA LIATEST VWF:AgClass II
BR81457600074STart Max®Class II
CA14567SPLI-PREST (LAYTEX)Class II
CA14572ASSERACHROM APA IGAClass II
CA14523FS TESTClass II

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