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Home›Netherlands›Screenpoint Medical B.V.

Screenpoint Medical B.V.

Netherlands · Nijmegen
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel — 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
3listed device types
Class I 1Class II 2Class III 0
plus 16 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
0active device licences
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States16 registration records, 8 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: ScreenPoint Medical, Inc. · SCREENPOINT MEDICAL · SCREENPOINT MEDICAL B.V.
Same-named companies — This database also contains companies with near-identical names: ScreenPoint Medical, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Netherlands
City
Nijmegen

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

12018
12019
12020
12021
12022
12023
12024
12026

FDA listed device types

Automated Radiological Image Processing Software 1Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer 1System, Digital Image Communications, Radiological 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260898Transpara (2.1.0)2026-08-14
USK241831Transpara (2.1.0)2024-11-25
USK232096Transpara Density 1.0.02023-12-11
BR81504790331TRANSPARAClass II

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