Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002945499

FEI Number

3002945499

Entity Name

BIOSIGMA SPA

City/State/Country

Cantarana di Cona (VE) Veneto, IT

Establishment Address

Via Valletta, 6, Cantarana di Cona (VE) Veneto 30010, IT

Establishment Type(s)

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

Owner / Operator

BIOSIGMA SPA (Owner Number: 10056112)

Owner / Operator Contact Address

Via Valletta, 6, Cantarana di Cona (VE), IT-34 30010, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CLEARLINE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2025-09-23

Official Correspondent

STEFANIA PIZZEGHELLO

US Agent Details

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

Related Public Records

Same Entity

BIOSIGMA SPA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3027605742	Xiamen Zhiyuan Medical Technology Co., Ltd.	XIAMEN Fujian, CN
2320762	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
3010420046	CITOTEST Labware Manufacturing CO., LTD.	Haimen Jiangsu, CN
3044466317	MEDINOVA GROUP CO.	Laguna Beach, CA, US
1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002945499. Last updated year: 2026. Please use registration number 3002945499 when referencing this establishment in official correspondence.