KARTELL SPA

FDA Device Registration & Listing · NOVIGLIO Milano, IT · Registration 1000354117

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1000354117
FEI Number
1000354117
Entity Name
KARTELL SPA
City/State/Country
NOVIGLIO Milano, IT
Establishment Address
VIA DELLE INDUSTRIE 1, NOVIGLIO Milano 20082, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
KARTELL SPA (Owner Number: 10056040)
Owner / Operator Contact Address
VIA DELLE INDUSTRIE 1, NOVIGLIO, IT-MI 20082, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2017-11-02

Official Correspondent

ANGELA LAROCCA

US Agent Details

Dennis Hoeft Business: Globe Scientific. Inc. Email: d.hoeft@globescientific.com Phone: (201) 5991400

Related Public Records

Same Entity

KARTELL SPA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000354117. Last updated year: 2026. Please use registration number 1000354117 when referencing this establishment in official correspondence.
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