Data / Medical devices / Italy / CORMAN spa
CORMAN spa: FDA-registered device maker in Lacchiarella (MI) Milano, Italy, 4 510(k) clearances
CORMAN spa is registered with the FDA (registration 3006241352) in Lacchiarella (MI) Milano, Italy. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 2, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006241352
- Address
- via Liguria 3, Lacchiarella (MI) Milano, Italy, 20084
- Owner or operator
- CORMAN / Mantovani (10022607)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 6, 2007
- Registered through
- 2026
- Brand names listed
- 100% Organic Cotton Menstrual Tampon, External pads, various brands and models, Light incontinence pads, various brands and models, Tampons with applicators, various brands and models, Tampons, various brands and models
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Garment, Protective, For Incontinence | EYQ | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Reusable | NUQ | 1 | Specification developer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Manufacturer | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Exporter to the US | 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 2, 2015 | K151170 | Tosama 100% Organic Cotton Menstrual Tampon | HEB | Substantially Equivalent | Tosama, D.O.O. | accessdata.fda.gov |
| April 23, 2014 | K132595 | ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS | HEB | Substantially Equivalent | Ontex Bvba | accessdata.fda.gov |
| December 23, 2009 | K090819 | ONTEX TAMPON (UNSCENTED) | HEB | Substantially Equivalent | Ontex International NV | 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 Pad, Menstrual, Unscented
- All makers of Pad, Menstrual, Reusable
- All makers of Garment, Protective, For Incontinence
Updated July 2, 2015. 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.