Data / Medical devices / Spain / Cotton High Tech S.L.
Cotton High Tech S.L.: FDA-registered device maker in Balsareny Barcelona, Spain, 6 510(k) clearances
Cotton High Tech S.L. is registered with the FDA (registration 3006517653) in Balsareny Barcelona, Spain. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006517653
- Address
- Colonia La Rabeia, s/n, Balsareny Barcelona, Spain, ES 08660
- Owner or operator
- COTTON HIGH TECH S.L. (10021857)
- Roles
- Manufacturer
- First device listed
- October 3, 2007
- Registered through
- 2026
- Brand names listed
- COHITECH Cottonlock Tampons with Reusable Applicator, COHITECH Menstrual cups S,M,L in bulk, COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS, COHITECH Organic Cotton Non-Applicator Cottonlock Tampons Light, Regular, Super, Super Plus, COHITECH Reusable Tampon Applicator, Size 1 (regular - super), COHITECH Reusable Tampon Applicator, Size 2 (super - super plus), COHITECH organic cotton compact applicator tampons light, regular, super, super plus, bulk, Menstrual Cup and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cup, Menstrual | HHE | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Manufacturer | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | 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 |
|---|---|---|---|---|---|---|
| October 9, 2025 | K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | HEB | Substantially Equivalent | Cotton High Tech S.L. | accessdata.fda.gov |
| February 25, 2022 | K220238 | Cohitech Cottonlock Tampons with Reusable Applicator | HEB | Substantially Equivalent | Cotton High Tech S.L. | accessdata.fda.gov |
| October 22, 2021 | K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | HEB | Substantially Equivalent | Cotton High Tech S.L. | accessdata.fda.gov |
| October 8, 2021 | K212479 | Cohitech Reusable Tampon Applicator | HEB | Substantially Equivalent | Cotton High Tech S.L. | accessdata.fda.gov |
| March 15, 2019 | K182813 | COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT | HEB | Substantially Equivalent | Cotton High Tech S.L. | accessdata.fda.gov |
| April 29, 2009 | K091084 | MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS | HEB | Substantially Equivalent | Cotton High Tech S.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Tampon, Menstrual, Unscented
- All makers of Cup, Menstrual
- All makers of Pad, Menstrual, Unscented
Updated October 9, 2025. 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.