FDA Registration
Active
🇪🇸 Spain
NEOMEDIC INTERNATIONAL
Reg #: 3004838863
·
FEI: 3004838863
·
Expires 2026
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- NEOMEDIC INTERNATIONAL
- Registration Number
- 3004838863
- FEI Number
- 3004838863
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MAESTRAT 41-43
- City
- TERRASA Barcelona
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K062341
Owner / Operator
- Firm Name
- NEOMEDIC INTERNATIONAL
- Operator Number
- 9067497
- Address
- C/ MAESTRAT 41-43, 1
- City
- TERRASSA
- State
- Barcelona
- Postal Code
- 08225
- Country
- ES
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, For Stress Urinary Incontinence, Male | OTM | Class 2 | General, Plastic Surgery | No | 2008-01-14 |
| Fixation, Non-Absorbable Or Absorbable, For Pelvic Use | PBQ | Class 2 | Obstetrics/Gynecology | No | 2012-11-20 |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | Class 2 | General, Plastic Surgery | No | 2012-01-05 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2016-09-23 |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | PAH | Class 2 | General, Plastic Surgery | No | 2008-01-18 |
| Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | OTP | Class 3 | Obstetrics/Gynecology | No | 2011-08-26 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device