Dignitana Inc

FDA Filings

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

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

DIGNITANA AB

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

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

Initial Importer

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

Registration Number	3012146457
FEI Number	3012146457
Name	Dignitana, Inc.
Owner & Operator	Dignitana Inc
Contact Address	10925 Estate LN Dallas TX 75238 US
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	10925 Estate Ln Dallas, TX 75238 US
Establishment Type	Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K191166 \| PMC Dignitana, Inc. [Dignitana Inc]	DigniCap Delta Scalp Cooling System	2019-08-16
PMN K191166 Dignitana Inc.	DigniCap Delta	2019-06-26
PMN DEN150010 \| PMC Dignitana, Inc. [Dignitana Inc]	The DigniCap? Scalp Cooling System	2016-01-11
PMN DEN150010 \| PMC Dignitana, Inc. [Dignitana Inc]	Spareparts	2016-01-11
PMN DEN150010 \| PMC Dignitana, Inc. [Dignitana Inc]	DigniCool	2016-01-11
PMN DEN150010 \| PMC Dignitana, Inc. [Dignitana Inc]	DigniCap cooling cap set	2016-01-11
PMN DEN150010 \| PMC Dignitana, Inc. [Dignitana Inc]	DigniC3	2016-01-11
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

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