ROYAL BIOLOGICS, INC.

FDA Device Registration & Listing · Hackensack, NJ, US · Registration 3015989622

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015989622
FEI Number
3015989622
Entity Name
ROYAL BIOLOGICS, INC.
City/State/Country
Hackensack, NJ, US
Establishment Address
401 Hackensack Ave, Suite 604, Hackensack, NJ 07601, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Royal Biologics, Inc. (Owner Number: 10061690)
Owner / Operator Contact Address
401 Hackensack Ave, Suite 604, Hackensack, NJ 07601, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK120008
PMA Number
N/A

All Registered Proprietary Names

Fibrinet PRF Wound Matrix System MAXX BMC Concentration System Fibrinet

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PMQ Peripheral Blood Processing Device For Wound Management Hematology Class 2 864.9245 2026-04-13
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2022-06-02
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2019-11-09

Official Correspondent

Adam Ferretti

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Royal Biologics, 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 3015989622. Last updated year: 2026. Please use registration number 3015989622 when referencing this establishment in official correspondence.
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