Identity
- Trade Name
- MOPTIM FDA UDI
- Generic Name
- Hand-held subjective ophthalmic refractometer FDA UDI
- Device Name
- The manual refractometer is composed of a lens and a removable eye chart. The testee is required to move the position of the eye chart after resetting to make the visual target become clearer from blur. Once the clearest position of the visual target is determined, the testee’s estimated refractive error can be read from the display screen of the instrument. FDA UDI
- Model / Reference
- iRef FDA UDI
- Description
- The manual refractometer is composed of a lens and a removable eye chart. The testee is required to move the position of the eye chart after resetting to make the visual target become clearer from blur. Once the clearest position of the visual target is determined, the testee’s estimated refractive error can be read from the display screen of the instrument. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972039971542 FDA UDI
- FDA Product Code
- HKO FDA UDI
- GMDN Term
- Hand-held subjective 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hand-held subjective ophthalmic refractometer
Moptim by Shenzhen CERTAINN Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held subjective ophthalmic refractometer.
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 739e0e61-6e70-4c41-a598-5869b8edd7a0 34 fields · synced May 30, 2026