HomeNetherlandsELITECHGROUP B.V. ALSO TRADING AS ELITECH CLINICAL SYSTEMS

ELITECHGROUP B.V. ALSO TRADING AS ELITECH CLINICAL SYSTEMS

Netherlands · Spankeren
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in Brazil, Canada, Taiwan, Singapore, Israel, Russia — 6 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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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
Same-named companies — This database also contains companies with near-identical names: ELITECH CLINICAL SYSTEMS SAS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Netherlands
City
Spankeren

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.

Registration details (sample)

MarketIdentifierNameClass / date
BR80615950264ICRP - TURBIClass II
BR80171840099MICROLAB 300Class II
BR80171840107UREA UV SL STD ElitechClass II
CA67845ELITECH CLINICAL SYSTEMS/ VIVA SYSTEMS - CLINICAL CHEMISTRY ANALYZERSClass III
CA86548ELITECH CLINICAL SYSTEMS GAMMA-GT SZASZ SLClass II
CA86549ELITECH CLINICAL SYSTEMS HBA1CClass II

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