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Home›Netherlands›GENOME DIAGNOSTICS B.V.

GENOME DIAGNOSTICS B.V.

Netherlands · Utrecht
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Australia, 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
5listed device types
Class I 1Class II 2Class III 0unclassified 2
plus 5 registration records and 2 510(k), 1 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
2 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
5 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
2active ARTG entries
IVD Class 3 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2b 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 States5 registration records, 2 510(k), 1 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: PERSONAL GENOME DIAGNOSTICS INC. · GENOME DIAGNOSTICS B.V. · GENOME DIAGNOSTICS B.V. (GENDX)
Same-named companies — This database also contains companies with near-identical names: Personal Genome Diagnostics, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Netherlands
City
Utrecht

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

12020 · K192063
12024 · DEN230046

FDA listed device types

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids 1Next Generation Sequencing Based Tumor Profiling Test 1Synthetic Next-Generation Sequencing Quality Control And Filler Material 1Tumor Gene Profiling Test 1Reagents For Molecular Diagnostic Test Systems 1

Registration details (sample)

MarketIdentifierNameClass / date
USDEN230046PGDx elio plasma focus Dx2024-08-01
USK192063PGDx elio tissue complete2020-04-24
CA73368ALLELESEQR HLA SEQUENCING KITSClass III

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