Auditdata A S

FDA Filings

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

FDA Registration(s)

• Registration Number: 3004052117
• FEI Number: 3004052117
• Name: Auditdata, LLC
• Owner & Operator: Auditdata A/S
• Contact Address: Dalbergstroeget 5-7 ; Taastrup DK-84 Region Hovedstaden 2630 DK
• Official Correspondent:
  • Dan Haugbol
  • 45-70-203124-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1220 Valley Forge Road, Suite A ; Phoenixville, PA 19460 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3008386587
• FEI Number: 3008386587
• Name: Dan Haugboel
• Owner & Operator: Auditdata A/S
• Contact Address: Dalbergstroeget 5-7 ; Taastrup DK-84 Region Hovedstaden 2630 DK
• Official Correspondent:
  • Dan Haugbol
  • 45-70-203124-x
• US Agent:
  • Dan Haugboel
  • Auditdata LLC
  • 610 7689300
  • dan@auditdata.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1220 Valley Forge Road, Suite 2 ; Phoenixville, PA 19460 US
• Establishment Type:
  • Foreign Private Label Distributor
  • Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3013596041
• FEI Number: 3013596041
• Name: Dan Haugboel
• Owner & Operator: Auditdata A/S
• Contact Address: Dalbergstroeget 5-7 ; Taastrup DK-84 Region Hovedstaden 2630 DK
• Official Correspondent:
  • Dan Haugbol
  • 45-70-203124-x
• US Agent:
  • Dan Haugboel
  • Auditdata LLC
  • 610 7689300
  • dan@auditdata.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1220 Valley Forge Road, Suite 2 ; Phoenixville, PA 19460 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 05711781004006 Auditdata A/S	Unity 3 21044734	2024-10-29
GUDID 05711781003818 Auditdata A/S	Unity 4 / Measure 21031179	2024-09-25
GUDID 05711781002743 Auditdata A/S	Measure 100.115	2024-09-25
GUDID 05711781003078 Auditdata A/S	Unity 4 / Measure 100.310	2024-08-29
GUDID 05711781002866 Auditdata A/S	Unity 4 / Measure 100.056	2024-08-29
GUDID 05711781002835 Auditdata A/S	Unity 4 / Measure 100.053	2024-08-29
GUDID 05711781002828 Auditdata A/S	Unity 4 / Measure 100.052	2024-08-29
GUDID 05711781002804 Auditdata A/S	Unity 4 / Measure 100.050	2024-08-29
GUDID 05711781002774 Auditdata A/S	Unity 4 / Measure 100.040	2024-08-29
GUDID 05711781002750 Auditdata A/S	Unity 4 100.116	2024-08-29
GUDID 05711781002736 Auditdata A/S	Unity 4 / Measure 100.114	2024-08-29
GUDID 05711781002729 Auditdata A/S	Unity 4 / Measure 100.113	2024-08-29
GUDID 00571178100316 Auditdata A/S	Unity 4 21031181	2024-08-29
GUDID 05711781002675 Auditdata A/S	Measure/Unity 4	2024-05-06
GUDID 05711781001739 Auditdata A/S	Primus By Auditdata	2020-03-05
GUDID 05711781001722 Auditdata A/S	OTOPro By Auditdata	2020-03-05
GUDID 05711781000022 Auditdata A/S	Primus By Auditdata	2020-03-05
GUDID 57117810001054 Auditdata A/S	Primus By Auditdata	2019-07-08
GUDID 05711781001715 Auditdata A/S	OTOSphere By Auditdata	2018-03-29
GUDID 05711781001685 Auditdata A/S	Primus By Auditdata	2018-03-29
GUDID 05711781001678 Auditdata A/S	Amplitude By Auditdata	2018-03-29
GUDID 05711781001661 Auditdata A/S	Amplitude By Auditdata	2018-03-29
GUDID 05711781001654 Auditdata A/S	OTOPod By Auditdata	2018-03-29
GUDID 05711781001647 Auditdata A/S	OTOPod By Auditdata	2018-03-29
GUDID 05711781001401 Auditdata A/S	Entomed By Auditdata	2018-03-29
GUDID 05711781001395 Auditdata A/S	Entomed By Auditdata	2018-03-29
GUDID 05711781001302 Auditdata A/S	Entomed By Auditdata	2018-03-29
GUDID 05711781001289 Auditdata A/S	Entomed By Auditdata	2018-03-29
GUDID 05711781001258 Auditdata A/S	Entomed By Auditdata	2018-03-29
GUDID 05711781001241 Auditdata A/S	Entomed By Auditdata	2018-03-29
GUDID 05711781001234 Auditdata A/S	Entomed By Auditdata	2018-03-29
GUDID 05711781001227 Auditdata A/S	Entomed By Auditdata	2018-03-29
GUDID 05711781001098 Auditdata A/S	Primus By Auditdata	2018-03-29
GUDID 05711781001050 Auditdata A/S	Primus By Auditdata	2018-03-29
ETW Dan Haugboel [Auditdata A/S]	Primus Hearing instrument test unit - PHITU	2014-12-09
ETW Dan Haugboel [Auditdata A/S]	Primus Hearing instrument test unit - PHITU	2014-12-09
ETW Dan Haugboel [Auditdata A/S]	OTOPro	2014-12-09
ETW Dan Haugboel [Auditdata A/S]	OTOPro	2014-12-09
ETW Dan Haugboel [Auditdata A/S]	2000 Primus HIT Pro	2014-12-09
ETW Dan Haugboel [Auditdata A/S]	2000 Primus HIT Pro	2014-12-09
ETW Auditdata, LLC [Auditdata A/S]	Primus Hearing instrument test unit - PHITU	2014-12-09
ETW Auditdata, LLC [Auditdata A/S]	OTOPro	2014-12-09
ETW Auditdata, LLC [Auditdata A/S]	2000 Primus HIT Pro	2014-12-09
ERA Dan Haugboel [Auditdata A/S]	2001 Primus Video Otoscope - PVO	2014-08-18
ERA Dan Haugboel [Auditdata A/S]	2001 Primus Video Otoscope - PVO	2014-08-18
ERA Auditdata, LLC [Auditdata A/S]	2001 Primus Video Otoscope - PVO	2014-08-18
PMN K113831 AUDITDATA A/S	PRIMUS HEARING INSTRUMENT TEST UNIT	2012-04-19
EWO Dan Haugboel [Auditdata A/S]	OTOSphere	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	OTOSphere	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	OTOPod	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	OTOPod	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	Entomed SA 204	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	Entomed SA 204	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	Entomed SA 203	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	Entomed SA 203	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	Entomed SA 202	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	Entomed SA 202	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	Entomed SA 201	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	Entomed SA 201	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	Amplitude T-Series	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	Amplitude T-Series	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	2000 Primus fitting unit Pro - PFU Pro	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	2000 Primus fitting unit Pro - PFU Pro	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	2000 Primus fitting unit - PFU	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	2000 Primus fitting unit - PFU	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	2000 Primus fitting unit + - PFU+	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	2000 Primus fitting unit + - PFU+	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	2000 Primus Ice	2010-05-28
EWO Dan Haugboel [Auditdata A/S]	2000 Primus Ice	2010-05-28
EWO Auditdata, LLC [Auditdata A/S]	OTOSphere	2010-05-28
EWO Auditdata, LLC [Auditdata A/S]	OTOPod	2010-05-28
EWO Auditdata, LLC [Auditdata A/S]	Entomed SA 204	2010-05-28
EWO Auditdata, LLC [Auditdata A/S]	Entomed SA 203	2010-05-28
EWO Auditdata, LLC [Auditdata A/S]	Entomed SA 202	2010-05-28
EWO Auditdata, LLC [Auditdata A/S]	Entomed SA 201	2010-05-28
EWO Auditdata, LLC [Auditdata A/S]	Amplitude T-Series	2010-05-28
EWO Auditdata, LLC [Auditdata A/S]	2000 Primus fitting unit Pro - PFU Pro	2010-05-28
EWO Auditdata, LLC [Auditdata A/S]	2000 Primus fitting unit - PFU	2010-05-28
EWO Auditdata, LLC [Auditdata A/S]	2000 Primus fitting unit + - PFU+	2010-05-28
EWO Auditdata, LLC [Auditdata A/S]	2000 Primus Ice	2010-05-28