HomeUSAMEDICAL MODELING - A 3D SYSTEMS COMPANY

MEDICAL MODELING - A 3D SYSTEMS COMPANY

USA · Littleton
✓ 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
23listed device types
Class I 4Class II 17Class III 2
plus 34 registration records and 2 510(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 States34 registration records, 2 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: MEDICAL MODELING - A 3D SYSTEMS COMPANY · Medical Modeling Inc.
Same-named companies — This database also contains companies with near-identical names: Medical Modeling, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Littleton

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

12012 · K120956
12014 · K133907

FDA listed device types

showing 8 of 23
Ankle Arthroplasty Implantation System 1System, Image Processing, Radiological 1Driver, Wire, And Bone Drill, Manual 1Cranial Surgical Planning And Instrument Guides 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer 1Intervertebral Fusion Device With Bone Graft, Cervical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK133907VSP SYSTEM2014-01-22
USK120956VSP SYSTEM2012-12-12
BR10247530104GUIA CIRÚRGICOClass I

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