HomeBelgiumBIOCARTIS NV

BIOCARTIS NV

Belgium · Mechelen
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, 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
4listed device types
Class I 0Class II 3Class III 1
plus 4 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
4 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
5valid device licences
Class II 1Class III 4
SGSingaporeHSA SMDR
6device registrations
CLASS C 6
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
IVD Class 1 3IVD Class 3 2
HKHong KongMDACS
5valid listings
IVD C 5
ILIsraelAMAR
7registrations
RURussiaRoszdravnadzor
6active registrations
Class 2b 6
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, 1 510(k), 0 PMA
Brazil1 confirmed, 1 excluded
Manufacturer names merged into this page: BIOCARTIS NV

Company information

Country
Belgium
City
Mechelen

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

12023 · K211181

FDA listed device types

Real Time Nucleic Acid Amplification System 1Lynch Syndrome Test System 1Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers 1Nucleic Acid Based Assay, Microsatellite Instability 1

Registration details (sample)

MarketIdentifierNameClass / date
USK211181Idylla MSI Test2023-02-27
BR80117580473IdyllaClass II

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