3shape Medical A S

FDA Filings

This page includes the latest FDA filings for 3shape Medical 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: 3010700948
• FEI Number: 3010700948
• Name: 3SHAPE Medical A/S
• Owner & Operator: 3Shape A/S
• Contact Address: Holmens Kanal 7 ; Copenhagen K DK-84 Region Hovedstaden 1060 DK
• Official Correspondent:
  • David Rothkopf
  • 045-70-272620-x
• US Agent:
  • David Rothkopf
  • MEDIcept - US Agent
  • 508 2318842 20
  • 508 2318861
  • drothk@aol.com
• Importing Logistics Registration:
  • Importer: 3Shape Inc.
  • Address: 571 Central Ave Suite 109 ; New Providence, NJ 07974 UNITED STATES
  • Importer Type: sales office
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Holmens Kanal 7 ; Copenhagen K Region Hovedstaden, 1060 DK
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 05902729753265 3shape Medical A/S	Implant Studio	2020-11-02
PMN K202256 3Shape Medical A/S	3Shape Implant Studio	2020-09-09
GUDID 05902729750455 3shape Medical A/S	CT Preparation	2018-04-02
GUDID 05902729750448 3shape Medical A/S	Implant Studio	2018-04-02
GUDID 05902768365306 3shape Medical A/S	3Shape Implant Studio	2018-03-29
PMN K152078 3Shape Medical A/S	Implant Studio 2015	2015-12-04
PMN K141570 | LLZ 3SHAPE Medical A/S [3Shape A/S]	Implant Studio	2014-12-22
PMN K141570 3SHAPE MEDICAL A/S	IMPLANT STUDIO	2014-10-31