Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010273861

FEI Number

3010273861

Entity Name

ROLL Srl

City/State/Country

Piove di Sacco Padova, IT

Establishment Address

Via Leonardo Da Vinci 24/A, Piove di Sacco Padova 35028, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ROLL Srl DI FINOTTO MARTA E C (Owner Number: 10043005)

Owner / Operator Contact Address

Via Leonardo Da Vinci 24/A, Piove di Sacco, IT-PD 35028, 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	2013-01-18
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2013-01-18
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-01-18
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2013-01-18
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2017-12-29
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2013-01-18
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2013-01-18
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2013-01-18

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

ROLL Srl DI FINOTTO MARTA E C

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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3017771197	ZARAPAK SDN. BHD.	Perak, MY
3016648678	INNOVERO, LLC	Colorado Springs, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010273861. Last updated year: 2026. Please use registration number 3010273861 when referencing this establishment in official correspondence.