Data / Medical devices / Costa Rica / Coloplast Costa Rica SA
Coloplast Costa Rica SA: FDA-registered device maker in La Lima, Guadalupe Cartago, Costa Rica, 5 510(k) clearances
Coloplast Costa Rica SA is registered with the FDA (registration 3015131144) in La Lima, Guadalupe Cartago, Costa Rica. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 7, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3015131144
- Address
- Calle 58, Zona Franca La Lima, La Lima, Guadalupe Cartago, Costa Rica, 30106
- Owner or operator
- Coloplast Corp. (8010144)
- Roles
- Manufacturer
- First device listed
- September 8, 2005
- Registered through
- 2027
- Brand names listed
- Assura 1pc Kit, Assura CV Kit, Assura Kit, Assura Night bag, Assura Ostomy Pouch, Assura Urostomy Pouch, Assura Urostomy bag, Brava Belt for SenSura Mio and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Straight | EZD | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Urethral | GBM | 2 | Manufacturer | accessdata.fda.gov |
| Collector, Ostomy | EXB | 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 |
|---|---|---|---|---|---|---|
| July 7, 2026 | K262045 | Luja Soft | EZD | Substantially Equivalent | Coloplast A.S. | accessdata.fda.gov |
| April 26, 2022 | K210250 | SpeedCath Compact Male | EZD | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| July 30, 2020 | K200142 | SpeediCath Soft | GBM | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| July 10, 2019 | K190620 | SpeediCath Flex Coude Pro | GBM | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| October 25, 2018 | K180258 | SpeediCath Standard | GBM | Substantially Equivalent | Coloplast | accessdata.fda.gov |
Compare with other makers
Updated July 7, 2026. 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.