SQA-V Sperm Quality Analyzer AS-9081000

GUDID 07290016650037

M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

Spermatozoa/semen analyser IVD, automated

• Primary Device ID: 07290016650037
• NIH Device Record Key: 0822a160-37b8-4ea6-b79f-80ef1911ea95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SQA-V Sperm Quality Analyzer
• Version Model Number: AS-9081000
• Catalog Number: AS-9081000
• Company DUNS: 514680529
• Company Name: M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016650037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012352

FDA Product Code

• POV: Semen Analysis Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

• 07290016650402 - SQA-iO Sperm Quality Analyzer: 2023-09-14
• 07290012140136 - QwikCheck Beads: 2023-06-16
• 07290012140143 - QwikCheck Dilution Kit: 2023-06-16
• 07290012140150 - QwikCheck Liquefaction: 2023-06-16
• 07290012140600 - QwikCheck Beads Proficiency and Training Kit: 2023-06-16
• 07290012140891 - QwikCheck Vitality Kit: 2023-06-16
• 07290016650020 - QwikCheck Beads Precision and Linearity kit: 2023-06-16
• 07290016650617 - QwikCheck DFI Kit: 2023-06-16