YO Home Sperm Test

Basic Information

• Brand Name: YO Home Sperm Test
• Primary DI: 07290016650785
• Version / Model: YO: Universal 3.0 packed kit for Bird & Be - 3 tests
• Company Name: M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
• Labeler DUNS: 514680529
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-16
• Public Version: 1
• Public Version Date: 2025-01-24
• Public Version Status: New
• Public Device Record Key: 4cb11312-2934-4486-a855-4c991d344fbf

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
POV	Semen Analysis Device	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61920	Motile sperm concentration IVD, kit, imaging, self-testing	A collection of devices intended to be used to visualize sperm and calculate motile sperm concentration in a semen specimen for the assessment of male fertility. It includes a magnifying lens and application software. The lens is intended to be attached to a compatible mobile communication device with a camera (not included) which runs the software to enable visualization and analysis of sperm in the semen specimen. It also includes materials to collect, process, and display the semen specimen. It is available [non-prescription] over-the-counter (OTC) for use in the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016650785	GS1

Premarket Submissions

Submission Number	Supplement Number
K241628	000