Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004838863

FEI Number

3004838863

Entity Name

NEOMEDIC INTERNATIONAL

City/State/Country

TERRASA Barcelona, ES

Establishment Address

MAESTRAT 41-43, TERRASA Barcelona 08225, ES

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

NEOMEDIC INTERNATIONAL (Owner Number: 9067497)

Owner / Operator Contact Address

C/ MAESTRAT 41-43, 1, TERRASSA, ES-B 08225, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male	General, Plastic Surgery	Class 2	878.3300	2008-01-14
PBQ	Fixation, Non-Absorbable Or Absorbable, For Pelvic Use	Obstetrics/Gynecology	Class 2	884.4530	2012-11-20
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2012-01-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2016-09-23

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

NEOMEDIC INTERNATIONAL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K222293	Urocure, LLC	ArcSP Suprapubic Sling System	2022-09-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004838863. Last updated year: 2026. Please use registration number 3004838863 when referencing this establishment in official correspondence.