Scibase Ab

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008285458
• FEI Number: 3008285458
• Name: SCIBASE AB
• Owner & Operator: Scibase AB
• Contact Address: Landsvagen 39 ; Sundbyberg SE-AB Stockholms lan [SE-01] 17263 SE
• Official Correspondent:
  • Simon J Grant
  • 46-72-8874399-x
• US Agent:
  • Cherita James
  • M Squared Associates, Inc
  • 347 9540624
  • 703 5629797
  • cjames@MSquaredAssociates.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Landsvagen 39 ; sundbyberg Stockholms lan [SE-01], 17263 SE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P150046S004 SCIBASE AB	Nevisense	2020-04-30
GUDID 07350094440279 Scibase AB	NeviFile kit US 142-0013	2019-03-04
PMA P150046S002 SCIBASE AB	Nevisense	2019-01-14
PMA P150046S003 SCIBASE AB	Nevisense	2018-12-11
PMA P150046S001 SCIBASE AB	Nevisense	2018-07-13
GUDID 07350094440217 Scibase AB	Training electrode Sterile - 6 pcs 131-0008	2018-07-06
GUDID 07350094440200 Scibase AB	Single Use Electrodes Sterile - 6 pcs 131-0007	2018-07-06
GUDID 07350094440194 Scibase AB	Control Unit Battery 521-0001	2018-07-06
GUDID 07350094440101 Scibase AB	Test Impedance Tool 590-0002	2018-07-06
GUDID 07350094440095 Scibase AB	Probe cable 730-0009	2018-07-06
GUDID 07350094440088 Scibase AB	Probe unit 512-0003	2018-07-06
GUDID 07350094440071 Scibase AB	Nevisense 511-0001	2018-07-06
PMN P150046 | ONV SCIBASE AB	Nevisense	2017-07-06
PMA P150046 SCIBASE AB	NEVISENSE	2017-06-28