Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038611208

FEI Number

3038611208

Entity Name

MENTICE SPAIN S.L.

City/State/Country

Barcelona Catalonia, ES

Establishment Address

Rambla Catalunya, 53-55, 4-H, Barcelona Catalonia 08007, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Mentice Spain S.L. (Owner Number: 10093573)

Owner / Operator Contact Address

Rambla Catalunya, 53-55, 4-H, Barcelona, ES-CT 08007, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250160

PMA Number

N/A

All Registered Proprietary Names

Ankyras

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PZO	Software For Visualization Of Vascular Anatomy And Intravascular Devices	Radiology	Class 2	892.2050	2025-06-05

Official Correspondent

Hector Fernandez

US Agent Details

REGULATORY PHARMA WORLD LLC REGULATORY PHARMA WORLD LLC Email: info@afpharmaservice.com Phone: (689) 2471190

Related Public Records

Same Entity

Mentice Spain S.L.

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
K250160	Mentice Spain S.L.	ANKYRAS	2025-05-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038611208. Last updated year: 2026. Please use registration number 3038611208 when referencing this establishment in official correspondence.