Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026062723

FEI Number

3026062723

Entity Name

VITO HEALTH PTY LTD

City/State/Country

CARLTON Victoria, AU

Establishment Address

333 DRUMMOND STREET, CARLTON Victoria 3053, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Vito Health Pty Ltd (Owner Number: 10086901)

Owner / Operator Contact Address

333 DRUMMOND STREET, CARLTON, AU-VIC 3053, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sapyen Test Kit Mail-In Semen Analysis Advanced Home Semen Analysis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2023-01-03

Official Correspondent

Basim Zaidi

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Vito Health Pty Ltd

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 3026062723. Last updated year: 2026. Please use registration number 3026062723 when referencing this establishment in official correspondence.