Mastercare Ab

FDA Filings

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

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

• MASTERCARE AB

FDA Registration(s)

• Registration Number: 8032035
• FEI Number: 3003716588
• Name: MASTERCARE AB
• Owner & Operator: MASTERCARE AB
• Contact Address: SMEDSTORPSGATAN 16 ; SKARA SE-NOTA 53237 SE
• Official Correspondent:
  • MAGNUS J JANSSON
  • 46-511-21108-x
• US Agent:
  • Jerry Doane
  • Pragmatic Compliance LLC
  • 716 7750533
  • jdoane@usagent-tobias.com
• Importing Logistics Registration:
  • Importer: Mastercare AB
  • Address: Smedstorpsgatan 16 ; Skara, 53237 SWEDEN
  • Email Address: magnus@mastercares.se
  • Phone: 46 511 21108
  • FAX: 46 511 18383
  • Subdivision: SE-O
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: SMEDSTORPSGATAN 16 ; SKARA Vastra Gotalands lan [SE-14], 53237 SE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
ION MASTERCARE AB	Swedish Backcare System	1990-01-19
ION MASTERCARE AB	Mastercare	1990-01-19
ION MASTERCARE AB	Back-A-Traction	1990-01-19

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081112757	Shanghai ,China (Mainland) -> Savannah, Georgia	THE MASTER CARE BACK	278 PKG