Data / Medical devices / Sweden / M Dialysis AB
M Dialysis AB: FDA-registered device maker in Stockholm, Sweden, 2 510(k) clearances
M Dialysis AB is registered with the FDA (registration 3003733874) in Stockholm, Sweden. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 27, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003733874
- Address
- Hammarby Fabriksvag 43, Stockholm, Sweden, SE-120 30
- Owner or operator
- M Dialysis AB (9010619)
- Roles
- Manufacturer
- First device listed
- February 12, 2008
- Registered through
- 2026
- Brand names listed
- 63 MD Catheter 40/30, Cerebral Tissue Monitoring System, Reagents for Iscus flex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Peritoneal | GBW | 1 | Manufacturer | accessdata.fda.gov |
| Device, Monitoring, Intracranial Pressure | GWM | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | 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 |
|---|---|---|---|---|---|---|
| June 27, 2008 | K071984 | MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM | GWM | Substantially Equivalent | Cma Microdialysis AB | accessdata.fda.gov |
| October 23, 2002 | K020285 | CMA CEREBRAL TISSUE MONITORING SYSTEM | GWM | Substantially Equivalent | Cma Microdialysis AB | accessdata.fda.gov |
Compare with other makers
- All makers of General Purpose Reagent
- All makers of Device, Monitoring, Intracranial Pressure
- All makers of Catheter, Peritoneal
Updated June 27, 2008. 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.