Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005132313

FEI Number

3005132313

Entity Name

FRESCO INTERNATIONAL 2005 S.A.

City/State/Country

BARCELONA, SPAIN, ES

Establishment Address

SICILIA 143, BARCELONA, SPAIN 08013, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FRESCO INTERNATIONAL 2005 S.A. (Owner Number: 9081820)

Owner / Operator Contact Address

SICILIA 143, --, BARCELONA, SPAIN, ES-NOTA 08013, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Deramed Vitagel Profoot Dainamed Profoot Deramed

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2012-01-03
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2007-09-12
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2017-05-02

Official Correspondent

No official correspondent registered.

US Agent Details

Luke Matthews Business: Tommie Copper Email: luke.matthews@tommiecopper.com Phone: (646) 5527634

Related Public Records

Same Entity

FRESCO INTERNATIONAL 2005 S.A.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005132313. Last updated year: 2026. Please use registration number 3005132313 when referencing this establishment in official correspondence.