Winx Health Inc

FDA Device Registration & Listing · Reading, PA, US · Registration 3015729142

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
3015729142
FEI Number
3015729142
Entity Name
Winx Health Inc
City/State/Country
Reading, PA, US
Establishment Address
184 Tuckerton Rd, Unit 2, Reading, PA 19605, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Winx Health Inc (Owner Number: 10061060)
Owner / Operator Contact Address
9450 Southwest Gemini Drive, PMB 53351, Beaverton, OR 97008, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stix Ovulation Test stix pregnancy test Stix UTI test Stix Pantyliner

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 2019-12-06
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2019-08-07
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2020-09-15
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2020-09-15
HHD Pad, Menstrual, Unscented Obstetrics/Gynecology Class 1 884.5435 2021-05-04

Official Correspondent

Cynthia Plotch

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K964108 Direct Access Diagnostics FACT PLUS PREGNANCY TEST 1996-11-18
K945514 Princeton BioMeditech Corp. LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG 1995-02-10
K150022 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream 2015-08-07
K043443 Guangzhou Wondfo Biotech Co., Ltd. ONE STEP HCG URINE PREGNANCY TEST 2005-04-08
K173229 Guangzhou Wondfo Biotech Co., Ltd. Preview Digital Pregnancy Test 2018-03-12

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
Z-0042-2024 Universal Meditech Inc. 2
One Step Pregnancy Test REF 100-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015729142. Last updated year: 2026. Please use registration number 3015729142 when referencing this establishment in official correspondence.
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