Home›France›DIAGNOSTICA STAGO S.A.S.

DIAGNOSTICA STAGO S.A.S.

France · Gennevilliers

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 25 510(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

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

62device registrations

CLASS B 46CLASS C 16

KRSouth KoreaMFDS GMP

5GMP quality-system certificates

IVD import 5

AUAustraliaTGA ARTG

10active ARTG entries

IVD Class 1 3IVD Class 2 7

HKHong KongMDACS

17valid listings

IVD B 11IVD C 6

ILIsraelAMAR

21registrations

RURussiaRoszdravnadzor

11active registrations

Class 1 3Class 2a 8

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, 25 510(k), 0 PMA

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.

FDA 510(k) clearances by year

52001

32006

22008

42009

12010

12011

22013

22014

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)

Market	Identifier	Name	Class / date
US	K253658	STA Satellite Max®	2026-04-27
US	K212183	STA R Max 3, STA Compact Max 3	2023-06-07
US	K211485	STA- NeoPTimal	2022-12-23
BR	81457600071	FAMILIA STA® RIVAROXABAN	Class II
BR	81457600072	FAMÍLIA STA LIATEST VWF:Ag	Class II
BR	81457600074	STart Max®	Class II
CA	14567	SPLI-PREST (LAYTEX)	Class II
CA	14572	ASSERACHROM APA IGA	Class II
CA	14523	FS TEST	Class II