Data / Medical devices / Spain / Neomedic International
Neomedic International: FDA-registered device maker in TERRASA Barcelona, Spain, 6 510(k) clearances
Neomedic International is registered with the FDA (registration 3004838863) in TERRASA Barcelona, Spain. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 12, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004838863
- Address
- Maestrat 41-43, TERRASA Barcelona, Spain, 08225
- Owner or operator
- NEOMEDIC INTERNATIONAL (9067497)
- Roles
- Exporter to the US
- First device listed
- January 14, 2008
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fixation, Non-Absorbable Or Absorbable, For Pelvic Use | PBQ | 2 | Exporter to the US | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Exporter to the US | accessdata.fda.gov |
| Mesh, Surgical, For Stress Urinary Incontinence, Male | OTM | 2 | Exporter to the US | accessdata.fda.gov |
| Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | OTP | 3 | Exporter to the US | accessdata.fda.gov |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | PAH | 2 | Exporter to the US | accessdata.fda.gov |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | 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 |
|---|---|---|---|---|---|---|
| October 12, 2012 | K120831 | ANCHORSURE | PBQ | Substantially Equivalent | Neomedic International S.L. | accessdata.fda.gov |
| December 20, 2011 | K103022 | KIM | OTN | Substantially Equivalent | Neomedic International S.L. | accessdata.fda.gov |
| July 7, 2011 | K102815 | SURELIFT PROLAPSE SYSTEM | OTP | Substantially Equivalent | Neomedic International | accessdata.fda.gov |
| December 19, 2006 | K063136 | NEEDLELESS SLING | PAH | Substantially Equivalent | Specialities Remeex International, S.L. | accessdata.fda.gov |
| November 2, 2006 | K062341 | MALE REMEEX SYSTEM | OTM | Substantially Equivalent | Specialities Remeex International, S.L. | accessdata.fda.gov |
| January 15, 2004 | K033310 | REMEEX SYSTEM FOR URINARY INCONTINENCE | OTN | Substantially Equivalent | Specialities Remeex International, S.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- All makers of Mesh, Surgical, For Stress Urinary Incontinence, Male
- All makers of Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
- All makers of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
- All makers of Instrument, Manual, Surgical, General Use
Updated October 12, 2012. 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.