Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016245321

FEI Number

3016245321

Entity Name

IUL SA

City/State/Country

Barcelona, ES

Establishment Address

Ciutat Asuncion 4, Barcelona 08030, ES

Establishment Type(s)

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

Owner / Operator

IUL SA (Owner Number: 10061878)

Owner / Operator Contact Address

Ciutat Asuncion 4, Barcelona, ES-B 08030, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iPeak Europium iPeak, iPeak+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2022-12-21
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2019-11-29

Official Correspondent

Vicente Font

US Agent Details

Mireia Muriel Masanes Business: IUL Inc. Email: mireia@iul-inst.com Phone: (571) 4471982

Related Public Records

Same Entity

IUL SA

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
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

Similar Registrations

Registration Number	Establishment Name	Location
3004529019	Tosoh Hi-Tec, Inc.	Yamaguchi, JP
3009092698	NANOENTEK INC	Seoul, KR
3029916095	Precision Biosensor Inc. 2nd Factory	Yuseong-gu Daejeon, KR
3012516456	ANZA PACKAGING & DISPLAYS DE MEXICO S. DE R.L. DE C.V.	TIJUANA Baja California, MX
3010381606	EMSERE BV	Leiden Zuid-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016245321. Last updated year: 2026. Please use registration number 3016245321 when referencing this establishment in official correspondence.