Data / Medical devices / Sweden / Redsense Medical AB
Redsense Medical AB: FDA-registered device maker in Halmstad Halland, Sweden, 4 510(k) clearances
Redsense Medical AB is registered with the FDA (registration 3006948863) in Halmstad Halland, Sweden. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated November 22, 2013. Registered through 2026. FDA data exported November 3, 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.
- FDA registration number
- 3006948863
- Address
- Storgatan 36, Halmstad Halland, Sweden, 302 43
- Owner or operator
- Redsense Medical AB (10025092)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 13, 2008
- Registered through
- 2026
- Brand names listed
- Redsense Medical, Redsense alarm system, Redsense alarm unit and sensor, Redsense home use
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Autonomous Extracorporeal Blood Leak Detector/Alarm | ODX | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 22, 2013 | K130554 | REDSENSE ALARM SYSTEM | ODX | Substantially Equivalent | Redsense Medical AB | accessdata.fda.gov |
| February 10, 2011 | K103242 | REDSENSE-ALARM UNIT AND SENSOR | ODX | Substantially Equivalent | Redsense Medical AB | accessdata.fda.gov |
| May 10, 2010 | K092955 | REDSENSE-HOME USE | ODX | Substantially Equivalent | Redsense Medical AB | accessdata.fda.gov |
| October 18, 2007 | K071013 | REDSENSE | ODX | Substantially Equivalent | Redsense Medical AB | accessdata.fda.gov |
Compare with other makers
Updated November 22, 2013. 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.