Data / Medical devices / Costa Rica / Cooper Medical, SRL
Cooper Medical, SRL: FDA-registered device maker in La Garita Alajuela, Costa Rica, 1 510(k) clearance
Cooper Medical, SRL is registered with the FDA (registration 3014295858) in La Garita Alajuela, Costa Rica. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 13, 2002. Registered through 2027. 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
- 3014295858
- Address
- Edificio N B49, 51 Ave 0 Parque Industrial Zona Franca Coyol, La Garita Alajuela, Costa Rica, 20113
- Owner or operator
- COOPERSURGICAL, INC. (9002384)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 6, 2007
- Registered through
- 2027
- Brand names listed
- 10100060A, 10105060A, 10100500A, 10100060D, 10105060D, 10100500D, 10100060F, 10105060F, 10100500F, 10100060M, 10105060M, 10100500M, 10264010A, 10984010A, 10264010D, 10984010D, 10264010F, 10984010F, 10300060, 10301010, 10305060, 10310060, 10311010, 10315060 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Intrauterine Insemination | MFD | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Assisted Reproduction | MQF | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Labware, Assisted Reproduction | MQK | 2 | Contract manufacturer | accessdata.fda.gov |
| Media, Reproductive | MQL | 2 | Contract manufacturer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes) | MQH | 2 | Contract manufacturer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Assisted Reproduction | MQE | 2 | Contract manufacturer | accessdata.fda.gov |
| Pessary, Vaginal | HHW | 2 | Contract manufacturer | accessdata.fda.gov |
| Semen Analysis Device | POV | 2 | Contract manufacturer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Contract manufacturer | accessdata.fda.gov |
| Stapler, Skin | QQS | 1 | Contract 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 |
|---|---|---|---|---|---|---|
| December 13, 2002 | K023383 | COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER | MQF | Substantially Equivalent | Cooper Surgical | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Reproductive
- All makers of Stapler, Skin
- All makers of Needle, Assisted Reproduction
- All makers of Catheter, Assisted Reproduction
- All makers of Microtools, Assisted Reproduction (Pipettes)
- All makers of Staple, Implantable
Updated December 13, 2002. 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.