Dignitana Ab

FDA Filings

This page includes the latest FDA filings for Dignitana 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: 3008888703
• FEI Number: 3008888703
• Name: DIGNITANA AB
• Owner & Operator: Dignitana Inc
• Contact Address: 10925 Estate LN ; Dallas TX 75238 US
• US Agent:
  • N/A
  • N/A
  • 0
  • N/A
• Importing Logistics Registration:
  • Importer: Dignitana Inc.
  • Address: 10925 Estate Ln ; Dallas, TX 75238 UNITED STATES
  • Email Address: info@dignitana.com
  • Phone: 1 214 6938614
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Traktorgranden 3 ; Lund Skane lan [SE-12], 22660 SE
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00850036106333 Dignitana AB	DigniCap® Delta 800-1004	2022-02-10
GUDID 00850036106326 Dignitana AB	DigniCap® Delta 800-1003	2022-02-10
GUDID 00850036106319 Dignitana AB	DigniCap® Delta 800-1002	2022-02-10
GUDID 00850036106234 Dignitana AB	DigniCap® Delta 800-1104	2022-02-10
GUDID 00850036106180 Dignitana AB	DigniCap® Delta 800-2003	2022-02-10
GUDID 00850036106173 Dignitana AB	DigniCap® Delta 800-2002	2022-02-10
GUDID 00850036106166 Dignitana AB	DigniCap® Delta 800-2001	2022-02-10
GUDID 00850036106074 Dignitana AB	DigniCap® Delta 800-1001	2022-02-10
GUDID 00850036106036 Dignitana AB	DigniCap® Delta 900-2001	2022-02-10
GUDID 00850036106005 Dignitana AB	DigniCap® Delta 900-1001	2022-02-10
GUDID 00850036106302 Dignitana AB	DigniCap® Delta 700-1006	2022-02-09
GUDID 00850036106296 Dignitana AB	DigniCap® Delta 700-1005	2022-02-09
GUDID 00850036106289 Dignitana AB	DigniCap® Delta 700-1004	2022-02-09
GUDID 00850036106210 Dignitana AB	DigniCap® Delta 800-1103	2022-02-09
GUDID 00850036106197 Dignitana AB	DigniCap® Delta 800-1102	2022-02-09
GUDID 00850036106159 Dignitana AB	DigniCap® Delta 800-1201	2022-02-09
GUDID 00850036106272 Dignitana AB	DigniCap® Delta 700-1003	2022-02-08
GUDID 00850036106265 Dignitana AB	DigniCap® Delta 700-1002	2022-02-08
GUDID 00850036106258 Dignitana AB	DigniCap® Delta 700-1001	2022-02-08
GUDID 07350002100097 Dignitana AB	DigniCool REF 11010	2018-03-29
GUDID 07350002100080 Dignitana AB	DigniCool REF 11000	2018-03-29
GUDID 07350002100073 Dignitana AB	DigniCap REF 13700	2018-03-29
GUDID 07350002100066 Dignitana AB	DigniCap REF 13600	2018-03-29
GUDID 07350002100059 Dignitana AB	DigniCap REF 13500	2018-03-29
GUDID 07350002100042 Dignitana AB	DigniCap REF 13400	2018-03-29
GUDID 07350002100035 Dignitana AB	DigniCap REF 13900	2018-03-29
GUDID 07350002100028 Dignitana AB	DigniCap Ref 13200	2018-03-29
GUDID 07350002100011 Dignitana AB	Digni C3 Ref 10033	2018-03-29
PMN K170871 Dignitana AB	DigniCap Scalp Cooling System	2017-07-03
PMN DEN150010 | PMC DIGNITANA AB [Dignitana Inc]	The DigniCap? Scalp Cooling System	2016-01-11
PMN DEN150010 | PMC DIGNITANA AB [Dignitana Inc]	Spareparts	2016-01-11
PMN DEN150010 | PMC DIGNITANA AB [Dignitana Inc]	DigniCool	2016-01-11
PMN DEN150010 | PMC DIGNITANA AB [Dignitana Inc]	DigniCap cooling cap set	2016-01-11
PMN DEN150010 | PMC DIGNITANA AB [Dignitana Inc]	DigniC3	2016-01-11
De Novo DEN150010 DIGNITANA AB	Dignitana AB DigniCap System	2015-12-08