Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005459839

FEI Number

3005459839

Entity Name

PRIM, S.A.

City/State/Country

Casarrubios del Monte Toledo, ES

Establishment Address

Avda. Constitucion, P-221, P.I. Monte Boyal, Casarrubios del Monte Toledo 45950, ES

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

PRIM,S.A. (Owner Number: 9012483)

Owner / Operator Contact Address

POLIGONO INDUSTRIAL NO.1,, CALLE YOLANDA GONZALEZ (Antigua CALLE F.) NO. 15, MOSTOLES, ES-M 28938, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COMFORSIL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2016-12-19
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2016-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

Solmarie Velez Rivera Business: Business Excellence Consulting, Inc. Email: solmarie@calidadpr.com Phone: (787) 7057272

Related Public Records

Same Entity

PRIM,S.A.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1000626221	PRIM,S.A.	Mostoles Madrid (Province), ES

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005459839. Last updated year: 2026. Please use registration number 3005459839 when referencing this establishment in official correspondence.