Device
For checking the refractive state of human eye.
Manufacturer
Chongqing Yeasn Science & Technology Co.,Ltd.
Chongqing Yeasn Science & Technology Co.,Ltd.
Model: YPA-2100S
DI: 06971922132299
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Distribution End: 2029-12-31
Description
For checking the refractive state of human eye.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a16275cf-39d7-4d99-8160-6374318bf5f9
Distribution Status:
In Commercial Distribution
DUNS Number:
547954649
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
06971922132299
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66911
Name: Phoropter, manual
Definition:
A manually-operated ophthalmic device intended to be placed in front of a patient's eyes to assist with measuring the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an examination, typically to determine a patient's prescription for glasses. Also known as a manual refractor, it typically consists of two mounted disk-like housings (head) which contain lenses of different characteristics. The optometrist manually changes the lenses and other settings while asking the patient to read an eye chart and provide subjective feedback on which settings give best vision.
FDA Product Codes
HKN
Refractor, Manual, Non-Powered, Including Phoropter