SIGMAPRO ENGINEERING & MANUFACTURING, LLC

FDA Device Registration & Listing · Fort Worth, TX, US · Registration 3011824610

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
3011824610
FEI Number
3011824610
Entity Name
SIGMAPRO ENGINEERING & MANUFACTURING, LLC
City/State/Country
Fort Worth, TX, US
Establishment Address
4760 Grants Lane, Fort Worth, TX 76179, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SigmaPro Engineering & Manufacturing, LLC (Owner Number: 10086743)
Owner / Operator Contact Address
4760 Grants Lane, Fort Worth, TX 76179, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Safen Medical Tag

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QMX Label Or Tag, Non-Sterile General, Plastic Surgery Class 1 878.4800 2022-12-07
QOI Intravenous Catheter Force-Activated Separation Device. General Hospital Class 2 880.5220 2026-01-05

Official Correspondent

Vivian Allen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SigmaPro Engineering & 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 3011824610. Last updated year: 2026. Please use registration number 3011824610 when referencing this establishment in official correspondence.
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