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:

• ASCOM SWEDEN AB
• Christopher S. Wood

FDA Registration(s)

• Registration Number: 3005334549
• FEI Number: 3005334549
• Name: Ascom (US) Inc.
• Owner & Operator: Ascom (Sweden) AB
• Contact Address: Grimbodalen 2 ; Goteborg SE-O Vastra Gotalands lan [SE-14] SE-41749 SE
• Official Correspondent:
  • Christopher Wood
  • 46-31-559451-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9024 Town Center Parkway ; Bradenton, FL 34202 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3008855170
• FEI Number: 3008855170
• Name: ASCOM US, INC.
• Owner & Operator: Ascom (Sweden) AB
• Contact Address: Grimbodalen 2 ; Goteborg SE-O Vastra Gotalands lan [SE-14] SE-41749 SE
• Official Correspondent:
  • Christopher Wood
  • 46-31-559451-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 300 Perimeter Park Dr Ste D ; Morrisville, NC 27560 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K180566 | MSX ASCOM US, INC. [Ascom (Sweden) AB]	Unite Connect for Clinical Systems	2019-04-18
IQA Ascom (US) Inc. [Ascom (Sweden) AB]	Unite View	2012-12-19
IQA Ascom (US) Inc. [Ascom (Sweden) AB]	Unite Connect For Nurse Call	2012-12-19
IQA Ascom (US) Inc. [Ascom (Sweden) AB]	Telligence	2012-12-19
IQA ASCOM US, INC. [Ascom (Sweden) AB]	Unite View	2012-12-19
IQA ASCOM US, INC. [Ascom (Sweden) AB]	Unite Connect For Nurse Call	2012-12-19
IQA ASCOM US, INC. [Ascom (Sweden) AB]	Telligence	2012-12-19
PMN K103634 | MSX ASCOM US, INC. [Ascom (Sweden) AB]	Cardiomax	2011-12-22
PMN K111215 | MSX ASCOM US, INC. [Ascom (Sweden) AB]	Ascom Mobile Monitoring Gateway (MMG)	2011-08-24
PMN K103634 ASCOM (US), INC.	ASCOM CLINICALCONNEX CARDIOMAX	2011-02-23

Related Finance Registrations

CAGE Code	3C854	ASCOM (US) INC. ASCOM WIRELESS SOLUTIONS
S.A.M. Registration	3C854 [804992340]	ASCOM (US) INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018072653926	Kaohsiung,China (Taiwan) -> Los Angeles, California	HANDEST HS CODE:8518.90	68 CTN