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3D MEDICAL SAS

France · Marolles En Brie Val-De-Marne

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

59listed device types

Class I 15Class II 39Class III 5

plus 116 registration records and 5 510(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

5 including historic records

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 States116 registration records, 5 510(k), 0 PMA, 47 excluded

Brazil1 confirmed, 11 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada0 confirmed, 6 excluded

Manufacturer names merged into this page: 3D MEDICAL MANUFACTURING, INC. (dba Tecomet) · MEDICAL MODELING - A 3D SYSTEMS COMPANY · 3D MEDICAL TECHNOLOGIES INC. · 3D MEDICAL SAS · 3D MEDICAL TECHNOLOGIES, INC. · 3D-SHAPER MEDICAL S.L

FDA 510(k) clearances by year

12007 · K061479

12008 · K080601

12014 · K140649

12022 · K220822

12025 · K251022

FDA listed device types

showing 8 of 59

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Ankle Arthroplasty Implantation System 1Rod, Fixation, Intramedullary And Accessories 1Densitometer, Bone 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Screw, Fixation, Bone 1

3D MEDICAL SAS

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies

Market	Identifier	Name	Class / date
US	K251022	3D-SHAPER	2025-09-05
US	K220822	3D-SHAPER	2022-12-09
US	K140649	VECTRIX EXTERNAL FIXATOR	2014-12-29
BR	80595310001	3D-Shaper	Class II