Data / Medical devices / Sweden / Dignitana AB
Dignitana AB: FDA-registered device maker in Lund Skane, Sweden, 2 510(k) clearances
Dignitana AB is registered with the FDA (registration 3008888703) in Lund Skane, Sweden. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 26, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008888703
- Address
- Traktorgranden 3, Lund Skane, Sweden, 22660
- Owner or operator
- Dignitana Inc (10050834)
- Roles
- Specification developer
- First device listed
- January 11, 2016
- Registered through
- 2026
- Brand names listed
- DigniCap, DigniCap Delta
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Scalp Cooling System | PMC | 2 | 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 |
|---|---|---|---|---|---|---|
| June 26, 2019 | K191166 | DigniCap Delta | PMC | Substantially Equivalent | Dignitana, Inc. | accessdata.fda.gov |
| December 8, 2015 | DEN150010 | Dignitana AB DigniCap System | PMC | Unknown | Dignitana AB | accessdata.fda.gov |
Compare with other makers
Updated June 26, 2019. 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.