Data / Medical devices / Sweden / Amra Medical AB
Amra Medical AB: FDA-registered device maker in Linkoping Ostergotland, Sweden, 1 510(k) clearance
Amra Medical AB is registered with the FDA (registration 3021593788) in Linkoping Ostergotland, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 24, 2021. 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.
- FDA registration number
- 3021593788
- Address
- Badhusgatan 5, Linkoping Ostergotland, Sweden, 58222
- Owner or operator
- AMRA Medical AB (10084178)
- Roles
- Manufacturer
- First device listed
- January 24, 2022
- Registered through
- 2026
- Brand names listed
- AMRA Profiler
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | 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 |
|---|---|---|---|---|---|---|
| November 24, 2021 | K211983 | AMRA Profiler | LNH | Substantially Equivalent | Amra Medical AB | accessdata.fda.gov |
Compare with other makers
Updated November 24, 2021. 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.