Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043364423

FEI Number

3043364423

Entity Name

SAMGEN MEDICAL LLC

City/State/Country

Cherry Hill, NJ, US

Establishment Address

1939 Route 70 E, Suite 220, Cherry Hill, NJ 08003, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Samgen Medical LLC (Owner Number: 10095285)

Owner / Operator Contact Address

1939 RT 70 East, Suite 220, Cherry Hill, NJ 08003, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Samgen Ankle Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2026-02-18

Official Correspondent

Matt Raimondo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Samgen Medical LLC

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 3043364423. Last updated year: 2026. Please use registration number 3043364423 when referencing this establishment in official correspondence.