Ascom Us Inc

FDA Filings

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

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

FDA Registration(s)
Registration Number3005334549
FEI Number3005334549
NameAscom (US) Inc.
Owner & OperatorAscom (Sweden) AB
Contact AddressGrimbodalen 2
Goteborg SE-O Vastra Gotalands lan [SE-14] SE-41749 SE
Official Correspondent
  • Christopher Wood
  • 46-31-559451-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9024 Town Center Parkway
Bradenton, FL 34202 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3008855170
FEI Number3008855170
NameASCOM US, INC.
Owner & OperatorAscom (Sweden) AB
Contact AddressGrimbodalen 2
Goteborg SE-O Vastra Gotalands lan [SE-14] SE-41749 SE
Official Correspondent
  • Christopher Wood
  • 46-31-559451-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address300 Perimeter Park Dr Ste D
Morrisville, NC 27560 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
ASCOM US, INC. [Ascom (Sweden) AB]
Unite Connect for Clinical Systems2019-04-18
Ascom (US) Inc. [Ascom (Sweden) AB]
Unite View2012-12-19
Ascom (US) Inc. [Ascom (Sweden) AB]
Unite Connect For Nurse Call2012-12-19
Ascom (US) Inc. [Ascom (Sweden) AB]
Telligence2012-12-19
ASCOM US, INC. [Ascom (Sweden) AB]
Unite View2012-12-19
ASCOM US, INC. [Ascom (Sweden) AB]
Unite Connect For Nurse Call2012-12-19
ASCOM US, INC. [Ascom (Sweden) AB]
Telligence2012-12-19
ASCOM US, INC. [Ascom (Sweden) AB]
Cardiomax2011-12-22
ASCOM US, INC. [Ascom (Sweden) AB]
Ascom Mobile Monitoring Gateway (MMG)2011-08-24
ASCOM (US), INC.
ASCOM CLINICALCONNEX CARDIOMAX2011-02-23

Related Finance Registrations
CAGE Code3C854ASCOM (US) INC. ASCOM WIRELESS SOLUTIONS
S.A.M. Registration3C854 [804992340]ASCOM (US) INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018072653926Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaHANDEST HS CODE:8518.9068 CTN

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