Isakssons Gummifabrik Ab

FDA Filings

This page includes the latest FDA filings for Isakssons Gummifabrik Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Isakssons Gummifabrik Ab holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Isakssons Gummifabrik AB

FDA Registration(s)

• Registration Number: 8030936
• FEI Number: 3008485807
• Name: Isakssons Gummifabrik AB
• Owner & Operator: ISAKSSONS GUMMIFABRIK AB
• Contact Address: Angalagsvagen 226 ; Bastad SE-M Skane lan [SE-12] 26995 SE
• Official Correspondent:
  • Christer Isaksson
  • 046-431-363160-x
• US Agent:
  • David Lennarz
  • Registrar Corp
  • 757 2240177
  • 757 2240179
  • david.lennarz@registrarcorp.com
• Importing Logistics Registration:
  • Importer: HERAEUS KULZER
  • Address: 300 HERAEUS WAY ; South Bend, IN 46614 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: Isakssons Gummifabrik AB
  • Address: Angalagsvagen 226 ; Bastad, 26995 SWEDEN
  • Importer Type: Agent
  • Subdivision: SE-M
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Angalagsvagen 226 ; Bastad Skane lan [SE-12], 26995 SE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
IOZ Isakssons Gummifabrik AB	Original - von Rosen - Splint	2014-05-16
EIE Isakssons Gummifabrik AB	Swedent	2010-09-22
EIE Isakssons Gummifabrik AB	Santay	2010-09-22
EIE Isakssons Gummifabrik AB	Orbis	2010-09-22
EIE Isakssons Gummifabrik AB	Jospi	2010-09-22
EIE Isakssons Gummifabrik AB	Ivory	2010-09-22