HUEDX

FDA Device Registration & Listing · Philadelphia, PA, US · Registration 3040090771

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
3040090771
FEI Number
3040090771
Entity Name
HUEDX
City/State/Country
Philadelphia, PA, US
Establishment Address
2929 Arch St Fl 4, Philadelphia, PA 19104, US
Establishment Type(s)
Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
HueDx (Owner Number: 10093949)
Owner / Operator Contact Address
2929 Arch St, Fl 4, Philadelphia, PA 19104, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HueFertility Luteinizing hormone Dipstick (Urine) LH Rapid Test Kit HueFertility Ovulation

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2025-08-20

Official Correspondent

Brianna Wronko

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HueDx
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040090771. Last updated year: 2026. Please use registration number 3040090771 when referencing this establishment in official correspondence.
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