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ELITECH CLINICAL SYSTEMS SAS

France · Sees

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in Brazil, Canada, South Korea — 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

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

56registered devices

Class I 3Class II 53

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

30active device licences

Class II 29Class III 1

31 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

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, 0 510(k), 0 PMA, 1 excluded

Brazil56 confirmed, 4 excluded

Canada30 confirmed, 1 excluded

Manufacturer names merged into this page: ELITECHGROUP B.V. ALSO TRADING AS ELITECH CLINICAL SYSTEMS · ELITECH CLINICAL SYSTEMS SAS · ELITECH CLINICAL SYSTEMS BV

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80615950264	ICRP - TURBI	Class II
BR	80171840099	MICROLAB 300	Class II
BR	80171840107	UREA UV SL STD Elitech	Class II
CA	67845	ELITECH CLINICAL SYSTEMS/ VIVA SYSTEMS - CLINICAL CHEMISTRY ANALYZERS	Class III
CA	86548	ELITECH CLINICAL SYSTEMS GAMMA-GT SZASZ SL	Class II
CA	86549	ELITECH CLINICAL SYSTEMS HBA1C	Class II

ELITECH CLINICAL SYSTEMS SAS

Registrations by market

How these numbers were verified

Company information

Registration details (sample)

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