Identity
- Trade Name
- MOPTIM FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- The key technique used in the easyRef Handheld Auto Refractometer is based on principle of Hartmann wave-front sensing. Light is emitted from the light source system inside the device, and then focuses on the bottom of the eye through the spectroscope and exit port, then the light is reflected back to the device, and beam through lens system and received by CCD camera. It is possible to calculate the diopter of the human eye by detecting the offset between the relative calibration light and the spot array formed by the light spot of each sub-aperture. FDA UDI
- Model / Reference
- easyRef FDA UDI
- Description
- The key technique used in the easyRef Handheld Auto Refractometer is based on principle of Hartmann wave-front sensing. Light is emitted from the light source system inside the device, and then focuses on the bottom of the eye through the spectroscope and exit port, then the light is reflected back to the device, and beam through lens system and received by CCD camera. It is possible to calculate the diopter of the human eye by detecting the offset between the relative calibration light and the spot array formed by the light spot of each sub-aperture. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972039971573 FDA UDI
- FDA Product Code
- HKN FDA UDI
- GMDN Term
- Automated ophthalmic refractometer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1770 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Automated ophthalmic refractometer
Moptim by Shenzhen CERTAINN Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Shenzhen CERTAINN Technology Co., Ltd.
Sources (1)
- FDA UDI 8625e917-1894-47d2-9c6f-9bf9658bd0bb 34 fields · synced Jun 1, 2026