Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009166014

FEI Number

3009166014

Entity Name

KEDRION S.P.A.

City/State/Country

Barga (Castelvecchio Pascoli) Lucca, IT

Establishment Address

Loc. Ai Conti, Barga (Castelvecchio Pascoli) Lucca 55051, IT

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Kedrion Biopharma Inc. (Owner Number: 10071674)

Owner / Operator Contact Address

Parker Plaza, 400 Kelby Street, 11th Floor, Fort Lee, NJ 07024, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK200456

PMA Number

N/A

All Registered Proprietary Names

GeTraP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2020-07-03

Official Correspondent

Nayana Lahoti

US Agent Details

Nayana Lahoti Business: Kedrion Biopharma Inc. Email: US_Regulatory@kedrion.com Phone: (201) 5828141

Related Public Records

Same Entity

Kedrion Biopharma Inc.

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 3009166014. Last updated year: 2026. Please use registration number 3009166014 when referencing this establishment in official correspondence.