Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040184668

FEI Number

3040184668

Entity Name

Entegrion Manufacturing, LLC

City/State/Country

Reno, NV, US

Establishment Address

9005 Double Diamond Pkwy Ste 30, Reno, NV 89521, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Entegrion Manufacturing, LLC (Owner Number: 10095536)

Owner / Operator Contact Address

4819 Emperor Boulevard, Suite 400, Durham, NC 27703, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VCM System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QFR	Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties	Hematology	Class 2	864.5430	2026-03-25

Official Correspondent

William Corbitt, III

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Entegrion Manufacturing, 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 3040184668. Last updated year: 2026. Please use registration number 3040184668 when referencing this establishment in official correspondence.