Materialise Colombia S A S

FDA Filings

This page includes the latest FDA filings for Materialise Colombia S A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011724582
• FEI Number: 3011724582
• Name: Materialise Colombia S.A.S
• Owner & Operator: MATERIALISE N.V.
• Contact Address: Technologielaan 15 --; Leuven BE-NOTA 3001 BE
• US Agent:
  • Jenny Jones
  • Global Quality Regulatory Manager, Medical
  • 734 2597017
  • jenny.jones@materialise.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Calle 29, 41-105, Loma San Julian Edificio Soho, interior 401; Medellin Antioquia, 050021 CO
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K173039 | JEY Materialise Colombia S.A.S [MATERIALISE N.V.]	TruMatch CMF Titanium 3D Printed Implant System	2018-09-07
PMN K173039 | JEY Materialise Colombia S.A.S [MATERIALISE N.V.]	TruMatch CMF Ti 3D-Printed Surgical Guides	2018-09-07
PMN K173039 | JEY Materialise Colombia S.A.S [MATERIALISE N.V.]	TruMatch CMF Ti 3D-Printed Plates	2018-09-07
PMN K173039 | JEY Materialise Colombia S.A.S [MATERIALISE N.V.]	TruMatch CMF Ti 3D-Printed Implants	2018-09-07
PMN K170272 | JEY Materialise Colombia S.A.S [MATERIALISE N.V.]	TruMatch CMF Titanium 3D Printed Implant System	2017-08-21
PMN K170272 | JEY Materialise Colombia S.A.S [MATERIALISE N.V.]	TruMatch CMF Ti 3D-Printed Surgical Guides	2017-08-21
PMN K170272 | JEY Materialise Colombia S.A.S [MATERIALISE N.V.]	TruMatch CMF Ti 3D-Printed Plates	2017-08-21
PMN K170272 | JEY Materialise Colombia S.A.S [MATERIALISE N.V.]	TruMatch CMF Ti 3D-Printed Implants	2017-08-21
PMN K111558 | HAW Materialise Colombia S.A.S [MATERIALISE N.V.]	SurgiCase CMF Guide	2012-04-11
PMN K111558 | HAW Materialise Colombia S.A.S [MATERIALISE N.V.]	ProPlan CMF Guide	2012-04-11
PMN K111641 | LLZ Materialise Colombia S.A.S [MATERIALISE N.V.]	SurgiCase	2011-12-21
PMN K111641 | LLZ Materialise Colombia S.A.S [MATERIALISE N.V.]	SurgiCase CMF	2011-12-21
PMN K111641 | LLZ Materialise Colombia S.A.S [MATERIALISE N.V.]	ProPlan CMF	2011-12-21
PMN K103136 | JEY Materialise Colombia S.A.S [MATERIALISE N.V.]	SurgiCase CMF Guides	2011-03-25
PMN K103136 | JEY Materialise Colombia S.A.S [MATERIALISE N.V.]	ProPlan CMF Guides	2011-03-25
HWT Materialise Colombia S.A.S [MATERIALISE N.V.]	SurgiCase Models	2003-12-11
HWT Materialise Colombia S.A.S [MATERIALISE N.V.]	SurgiCase CMF Models	2003-12-11
HWT Materialise Colombia S.A.S [MATERIALISE N.V.]	ProPlan CMF Models	2003-12-11
HWT Materialise Colombia S.A.S [MATERIALISE N.V.]	ProPlan CMF (Orthognathic Splints)	2003-12-11
HWT Materialise Colombia S.A.S [MATERIALISE N.V.]	HeartPrint	2003-12-11
HWT Materialise Colombia S.A.S [MATERIALISE N.V.]	AnatomyPrint	2003-12-11