Ascom Sweden Ab

FDA Filings

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

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: 3008952681
• FEI Number: 3008952681
• Name: ASCOM SWEDEN AB
• 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
• US Agent:
  • CHRISTOPHER S. WOOD
  • Ascom (US) Inc
  • 941 6845497
  • 941 3731767
  • christopher.wood@ascom.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Grimbodalen 2 ; Goteborg Vastra Gotalands lan [SE-14], SE-41749 SE
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

• 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
GUDID 17350088670979 Ascom (Sweden) AB	ASCOM	2022-08-04
GUDID 17350088670887 Ascom (Sweden) AB	Ascom	2022-08-04
GUDID 17350088670870 Ascom (Sweden) AB	Ascom	2022-08-04
GUDID 17350088670825 Ascom (Sweden) AB	Ascom	2022-08-04
GUDID 17350088670740 Ascom (Sweden) AB	Ascom	2022-02-09
GUDID 17350088670726 Ascom (Sweden) AB	Ascom	2021-03-08
GUDID 17350088670719 Ascom (Sweden) AB	Ascom	2021-01-14
GUDID 17350088671372 Ascom (Sweden) AB	Ascom	2020-09-07
GUDID 17350088671297 Ascom (Sweden) AB	Ascom	2020-01-23
GUDID 17350088671211 Ascom (Sweden) AB	ASCOM	2020-01-23
GUDID 17350088671174 Ascom (Sweden) AB	ASCOM	2020-01-23
GUDID 17350088670702 Ascom (Sweden) AB	ASCOM	2020-01-23
GUDID 17350088671259 Ascom (Sweden) AB	Ascom	2019-12-23
GUDID 17350088671273 Ascom (Sweden) AB	Ascom SW000466	2019-12-09
GUDID 17350088671266 Ascom (Sweden) AB	Ascom	2019-07-04
GUDID 17350088670610 Ascom (Sweden) AB	Ascom	2019-06-27
PMN K180566 | MSX ASCOM US, INC. [Ascom (Sweden) AB]	Unite Connect for Clinical Systems	2019-04-18
PMN K180566 | MSX ASCOM SWEDEN AB [Ascom (Sweden) AB]	Unite Connect for Clinical Systems	2019-04-18
GUDID 17350088671167 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088671129 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088671105 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088671075 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088671068 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088671044 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088671020 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088671013 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670863 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670849 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670832 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670580 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670573 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670566 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670559 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670542 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670528 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670511 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670504 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670498 Ascom (Sweden) AB	ASCOM	2019-04-08
GUDID 17350088670603 Ascom (Sweden) AB	Ascom	2019-02-11
GUDID 17350088670016 Ascom (Sweden) AB	Ascom SW000466	2018-07-06
GUDID 17350088670009 Ascom (Sweden) AB	Ascom SW000400	2018-07-06
PMN K180566 Ascom Sweden AB	Unite Connect For Clinical Systems	2018-04-03
GUDID 17350088670429 Ascom (Sweden) AB	Ascom SW000578	2018-03-29
GUDID 17350088670375 Ascom (Sweden) AB	Ascom SW000540	2018-03-29
GUDID 17350088670368 Ascom (Sweden) AB	Ascom	2018-03-29
GUDID 17350088670351 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670344 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670337 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670320 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670313 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670306 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670290 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670283 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670276 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670269 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670252 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670245 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670238 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670221 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670214 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670207 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670191 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670184 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670177 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670160 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670153 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670146 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670139 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670122 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670115 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670108 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670092 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670085 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670078 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670061 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670054 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670047 Ascom (Sweden) AB	ASCOM	2018-03-29
GUDID 17350088670023 Ascom (Sweden) AB	ASCOM	2018-03-29
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
IQA ASCOM SWEDEN AB [Ascom (Sweden) AB]	Unite View	2012-12-19
IQA ASCOM SWEDEN AB [Ascom (Sweden) AB]	Unite Connect For Nurse Call	2012-12-19
IQA ASCOM SWEDEN AB [Ascom (Sweden) AB]	Telligence	2012-12-19
PMN K103634 | MSX ASCOM US, INC. [Ascom (Sweden) AB]	Cardiomax	2011-12-22
PMN K103634 | MSX ASCOM SWEDEN AB [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 K111215 | MSX ASCOM SWEDEN AB [Ascom (Sweden) AB]	Ascom Mobile Monitoring Gateway (MMG)	2011-08-24
PMN K111215 ASCOM (SWEDEN) AB	ASCOM MOBILE MONITORING GATEWAY (MMG)	2011-07-05

Related Finance Registrations

NCAGE Code	AG35N	ASCOM (SWEDEN) AB
NCAGE Code	S7725	ASCOM (SWEDEN) AB
CAGE Code	S7725	ASCOM (SWEDEN) AB
CAGE Code	AG35N	ASCOM (SWEDEN) AB