Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1067085

FEI Number

3003457476

Entity Name

AMBRA LE ROY, LLC

City/State/Country

CHARLOTTE, NC, US

Establishment Address

8541 Crown Crescent Ct, CHARLOTTE, NC 28227, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

AMBRA LE ROY, LLC (Owner Number: 9047881)

Owner / Operator Contact Address

8541 Crown Crescent Ct, --, Charlotte, NC 28227, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-05-09
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2006-05-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMBRA LE ROY, 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 1067085. Last updated year: 2026. Please use registration number 1067085 when referencing this establishment in official correspondence.