Data / Medical devices / Sweden / Ascom Sweden AB

Ascom Sweden AB: FDA-registered device maker in Goteborg Vastra Gotaland, Sweden, 1 510(k) clearance

Name: Ascom Sweden AB FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ascom Sweden AB is registered with the FDA (registration 3008952681) in Goteborg Vastra Gotaland, Sweden. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 3, 2018. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Ascom Sweden AB

FDA registration number: 3008952681
Address: Grimbodalen 2, Goteborg Vastra Gotaland, Sweden, SE-41749
Owner or operator: ASCOM SWEDEN AB (10037837)
Roles: Manufacturer
First device listed: December 19, 2012
Registered through: 2026
Brand names listed: Telligence, Unite Connect For Nurse Call, Unite Connect for Clinical Systems, Unite View

Devices it lists

Device	Product code	Class	Role	Source
System, Environmental Control, Powered	IQA	2	Manufacturer	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 3, 2018	K180566	Unite Connect for Clinical Systems	MSX	Substantially Equivalent	Ascom Sweden AB	accessdata.fda.gov

Compare with other makers

Updated April 3, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.