SIMPLE HEALTHKIT

FDA Device Registration & Listing · Milpitas, CA, US · Registration 3024933340

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
3024933340
FEI Number
3024933340
Entity Name
SIMPLE HEALTHKIT
City/State/Country
Milpitas, CA, US
Establishment Address
446 S Hillview Dr, Milpitas, CA 95035, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Simple HealthKit (Owner Number: 10087271)
Owner / Operator Contact Address
446 S. Hillview Dr, Milpitas, CA 95035, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Container, Specimen Mailer And Storage, Non-Sterile - Simple HealthKit Stool Sample Collection Kit Container, Specimen Mailer And Storage, Sterile - Simple HealthKit Multipurpose Sample Collection Kit Urine Collection Kit (Excludes Hiv Testing) - Simple HealthKit Urine Sample Collection Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2023-09-27
KDT Container, Specimen Mailer And Storage, Sterile Pathology Class 1 864.3250 2023-09-27
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2023-02-13

Official Correspondent

Chirag Patel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Similar Registrations

Registration Number Establishment Name Location
3011213695 AHLSTROM GERMANY GMBH Barenstein Saxony, DE
3014787189 NOVOGENIA GMBH Eugendorf Salzburg, AT
3007261225 GENE BY GENE Houston, TX, US
3030125016 MED AUXIL ANALYSIS AIDS E.K. Seesen Lower Saxony, DE
3017067307 DYAD ENTERPRISE LLC King of Prussia, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024933340. Last updated year: 2026. Please use registration number 3024933340 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.