SQA-iO Sperm Quality Analyzer

Basic Information

• Brand Name: SQA-iO Sperm Quality Analyzer
• Primary DI: 07290016650402
• Version / Model: SQA-iO Sperm Quality Analyzer
• 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: 2023-09-06
• Public Version: 1
• Public Version Date: 2023-09-14
• Public Version Status: New
• Public Device Record Key: 83fe4f0c-48eb-46e3-86d2-a47dcfe4086d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
57855	Spermatozoa/semen analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of a semen specimen to assess volume, spermatozoa concentration, motility and/or morphological characteristics.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016650402	GS1

Premarket Submissions

Submission Number	Supplement Number
K220828	000