HomeBelgium3D-Side S.A.

3D-Side S.A.

Belgium · Mont-Saint-Guibert
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
7listed device types
Class I 0Class II 7Class III 0
plus 4 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
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 States4 registration records, 4 510(k), 0 PMA, 1 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: 3D-SIDE
Same-named companies — This database also contains companies with near-identical names: 3D-SIDE. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Belgium
City
Mont-Saint-Guibert

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

12021 · K212237
22022 · K221432
12025 · K243509

FDA listed device types

Automated Radiological Image Processing Software 1Shoulder Arthroplasty Implantation System 1Plate, Fixation, Bone 1Screw, Fixation, Bone 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1Orthopaedic Surgical Planning And Instrument Guides 1Shoulder Prosthesis, Reverse Configuration 1

Registration details (sample)

MarketIdentifierNameClass / date
USK243509Archer PSI System2025-05-12
USK221432Customize2022-08-03
USK213779Customize2022-03-16
BR81000030132Conjunto Template para CranioplastiaClass I

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