Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615139

FEI Number

1000553563

Entity Name

EUROSPITAL S.P.A.

City/State/Country

TRIESTE, IT

Establishment Address

VIA FLAVIA 122, TRIESTE 34147, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EUROSPITAL S.P.A. (Owner Number: 9039568)

Owner / Operator Contact Address

VIA FLAVIA 122, --, TRIESTE, IT-NOTA 34147, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130945

PMA Number

N/A

All Registered Proprietary Names

EasyCal PhiCal Test Fecal Extraction Device EasyCal Calprest®NG QUANTA Lite Calprotectin Extended Range Calprest

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2012-12-21
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2019-07-19
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2010-03-03
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2019-07-19
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2019-07-19
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2016-11-28
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2014-07-21

Official Correspondent

Giulia Kropf

US Agent Details

STEPHEN H. LIEBERMAN Email: lieberman@donawa.com Phone: (561) 3020777

Related Public Records

Same Entity

EUROSPITAL S.P.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 9615139. Last updated year: 2026. Please use registration number 9615139 when referencing this establishment in official correspondence.