Pure Global AI
FDA product code PBH

Embryo Image Assessment System, Assisted Reproduction

Obstetrics/GynecologyClass 221 CFR 884.6195
Verified
US regulatory classifications
US Product Code (FDA)
PBH
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 884.6195
View CFR Regulation
Medical specialty
Obstetrics/Gynecology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .

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About this record

Embryo Image Assessment System, Assisted Reproduction is a medical device type in the Obstetrics/Gynecology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.