Data / Medical devices / Switzerland / Compremium AG
Compremium AG: FDA-registered device maker in Muri Bern, Switzerland, 1 510(k) clearance
Compremium AG is registered with the FDA (registration 3022040661) in Muri Bern, Switzerland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022040661
- Address
- Worbststrasse 46, Muri Bern, Switzerland, 3074
- Owner or operator
- Compremium AG (10090973)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 10, 2024
- Registered through
- 2026
- Brand names listed
- CPMX1, Compremium Quantis ST
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Pressure, Intracompartmental | LXC | U | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| April 14, 2023 | K223509 | Compremium Compartment Compressibility Monitoring System (CPM#1) | LXC | Substantially Equivalent | Compremium AG | accessdata.fda.gov |
Compare with other makers
Updated April 14, 2023. 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.