Auditdata L L C

FDA Filings

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

Auditdata L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3004052117
FEI Number3004052117
NameAuditdata, LLC
Owner & OperatorAuditdata A/S
Contact AddressDalbergstroeget 5-7
Taastrup DK-84 Region Hovedstaden 2630 DK
Official Correspondent
  • Dan Haugbol
  • 45-70-203124-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1220 Valley Forge Road, Suite A
Phoenixville, PA 19460 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Auditdata, LLC [Auditdata A/S]
Primus Hearing instrument test unit - PHITU2014-12-09
Auditdata, LLC [Auditdata A/S]
OTOPro2014-12-09
Auditdata, LLC [Auditdata A/S]
2000 Primus HIT Pro2014-12-09
Auditdata, LLC [Auditdata A/S]
2001 Primus Video Otoscope - PVO2014-08-18
Auditdata, LLC [Auditdata A/S]
OTOSphere2010-05-28
Auditdata, LLC [Auditdata A/S]
OTOPod2010-05-28
Auditdata, LLC [Auditdata A/S]
Entomed SA 2042010-05-28
Auditdata, LLC [Auditdata A/S]
Entomed SA 2032010-05-28
Auditdata, LLC [Auditdata A/S]
Entomed SA 2022010-05-28
Auditdata, LLC [Auditdata A/S]
Entomed SA 2012010-05-28
Auditdata, LLC [Auditdata A/S]
Amplitude T-Series2010-05-28
Auditdata, LLC [Auditdata A/S]
2000 Primus fitting unit Pro - PFU Pro2010-05-28
Auditdata, LLC [Auditdata A/S]
2000 Primus fitting unit - PFU2010-05-28
Auditdata, LLC [Auditdata A/S]
2000 Primus fitting unit + - PFU+2010-05-28
Auditdata, LLC [Auditdata A/S]
2000 Primus Ice2010-05-28

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