FDA product code SBI
Manual Refractor, 3d Display
Ophthalmic·Class 1·21 CFR 886.1770
US regulatory classifications
- US Product Code (FDA)
- SBIView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 886.1770View CFR Regulation →
- Medical specialty
- Ophthalmic
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.
Search keywords
Click to search for similar devices in our global database
About this record
Manual Refractor, 3d Display is a medical device type in the Ophthalmic 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.