Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009107511

FEI Number

3009107511

Entity Name

FIDIA PHARMA USA INC.

City/State/Country

Florham Park, NJ, US

Establishment Address

100 Campus Drive, Suite 105, Florham Park, NJ 07932, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Fidia Pharma USA Inc. (Owner Number: 10037556)

Owner / Operator Contact Address

100 Campus Drive, Suite 105, Florham Park, NJ 07932, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RichPlat Ortho PRP System

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	2023-06-14
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2023-10-12

Official Correspondent

VIvian Kelly

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fidia Pharma USA 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 3009107511. Last updated year: 2026. Please use registration number 3009107511 when referencing this establishment in official correspondence.