inforMED
POVClass II

Semen Analysis Device

Hematology · 21 CFR 864.5220

Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.

MDR events1All time
Recalls2All time
Registered firms32Currently listed
510(k) clearances28All time

Recent MDR events

1 adverse event reports on file

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Event type breakdown

Malfunction1

Most-reported manufacturers

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Halotech, Srl. / Halotech Dna Sl1

Recalls

2 recall events for this product code

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Registered firms

32 firms currently registered for this product code

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510(k) clearances

28 clearances for this product code

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