HEALTH SUPPLY US LLC

FDA Device Registration & Listing · Mooresville, NC, US · Registration 3016760548

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
3016760548
FEI Number
3016760548
Entity Name
HEALTH SUPPLY US LLC
City/State/Country
Mooresville, NC, US
Establishment Address
205 Raceway Drive, Suite 3, Mooresville, NC 28117, US
Establishment Type(s)
Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Health Supply US LLC. (Owner Number: 10069823)
Owner / Operator Contact Address
205 Raceway Drive, Suite 3, Mooresville, NC 28117, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

American-Made Isolation Gown Level 2 (Poly L2, SMS L2) American-Made Isolation Gown Level 3 (SMS L3)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2021-05-24

Official Correspondent

Accounting Team

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Health Supply US 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 3016760548. Last updated year: 2026. Please use registration number 3016760548 when referencing this establishment in official correspondence.
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