Identity
- Trade Name
- YEASN FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- Eye refractometer is an electrically-powered, ophthalmic device designed to be used by an optometrist to objectively measure the refractive error of the eye by measuring how light is changed when it enters the patient's eyes. FDA UDI
- Model / Reference
- YPC-100K FDA UDI
- Description
- Eye refractometer is an electrically-powered, ophthalmic device designed to be used by an optometrist to objectively measure the refractive error of the eye by measuring how light is changed when it enters the patient's eyes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971922136525 FDA UDI
- FDA Product Code
- HKO FDA UDI
- GMDN Term
- Automated ophthalmic refractometer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Automated ophthalmic refractometer
Yeasn by Chongqing Yeasn Science & Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automated ophthalmic refractometer.
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- AUTO REF/KERATO/TONOMETER — Nidek, Inc. · Class II
- Remidio — Remidio Innovative Solutions Private Limited · Class I
- Visionix — RIGHT MFG. CO., LTD. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Chongqing Yeasn Science & Technology Co., Ltd.
Sources (1)
- FDA UDI 8fed6c04-7b3d-4d35-862e-6649f6fbcb1c 33 fields · synced May 30, 2026