SwimCount Sperm Quality Test

GUDID 00843277100048

Sperm quality test

Motilitycount ApS

Motile sperm concentration IVD, kit, rapid colorimetric, self-testing

• Primary Device ID: 00843277100048
• NIH Device Record Key: fc1bce3f-1b07-4c2f-9c59-afe1cc699b0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SwimCount Sperm Quality Test
• Version Model Number: 010116
• Company DUNS: 305237626
• Company Name: Motilitycount ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00843277100048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183602

FDA Product Code

• POV: Semen Analysis Device

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-25
• Device Publish Date: 2024-06-17