Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006994492

FEI Number

3006994492

Entity Name

INDUSTRIA FARMECEUTICA GALENICA SENESE S.R.L.

City/State/Country

Monteroni d'Arbia Siena, IT

Establishment Address

Via Cassia Nord 351, Monteroni d'Arbia Siena 53014, IT

Establishment Type(s)

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

Owner / Operator

Industria Farmeceutica Galenica Senese S.r.l. (Owner Number: 10051851)

Owner / Operator Contact Address

Via Cassia Nord 351, Monteroni d'Arbia, IT-SI 53014, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Platelet and plasma separator for bone graft handling

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2016-05-11

Official Correspondent

Danila Antonia Perillo

US Agent Details

Demos Global Group Inc. Demos Global Group Inc. Business: DemosGlobal Inc. Email: tm@demosglobal.es Phone: (305) 6700979

Related Public Records

Same Entity

Industria Farmeceutica Galenica Senese S.r.l.

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 3006994492. Last updated year: 2026. Please use registration number 3006994492 when referencing this establishment in official correspondence.