Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009520931

FEI Number

3009520931

Entity Name

F.L. MEDICAL S.R.L. UNIPERSONALE

City/State/Country

Torreglia Padova, IT

Establishment Address

Via Enrico Mattei, 20, Torreglia Padova 35038, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

F.L. MEDICAL s.r.l. Unipersonale (Owner Number: 10056044)

Owner / Operator Contact Address

Via Enrico Mattei, 20, Torreglia, IT-PD 35038, IT

Initial Importer Flag

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
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2017-10-30
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2017-10-30
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2026-03-25
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2022-02-02

Official Correspondent

Alessandro Fiore

US Agent Details

Lorenzo Da Madice Business: ISOPLAN USA Email: isoplan@fda-510k.com Phone: (386) 8680618

Related Public Records

Same Entity

F.L. MEDICAL s.r.l. Unipersonale

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 3009520931. Last updated year: 2026. Please use registration number 3009520931 when referencing this establishment in official correspondence.