Identity
- Trade Name
- AUTO REF/KERATOMETER FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- Structure: composed of optical imaging system, control system and display. Working principle: AUTO REF/KERATOMETER is to use infrared fundus reflex phase method, by launching a specific wavelength beam of infrared light, through the examiner cornea, lens and so on, finally projected onto the retina eyeball, then reflected back to the corresponding optical system, absorb the image by image sensor, after image processing, signal processing, calculate the ball lens diopter, axial column lens dioptre, column mirror, An instrument used to determine the refractive state of the human eye. AUTO REF/KERATOMETER can move in X axis, Y axis and Z axis at the same time, with 3D automatic eye tracking function. FDA UDI
- Model / Reference
- ARK-910 FDA UDI
- Description
- Structure: composed of optical imaging system, control system and display. Working principle: AUTO REF/KERATOMETER is to use infrared fundus reflex phase method, by launching a specific wavelength beam of infrared light, through the examiner cornea, lens and so on, finally projected onto the retina eyeball, then reflected back to the corresponding optical system, absorb the image by image sensor, after image processing, signal processing, calculate the ball lens diopter, axial column lens dioptre, column mirror, An instrument used to determine the refractive state of the human eye. AUTO REF/KERATOMETER can move in X axis, Y axis and Z axis at the same time, with 3D automatic eye tracking function. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971821402127 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
Yes
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
No
FDA UDI
Category: Automated ophthalmic refractometer
Auto Ref/Keratometer by Ningbo Ming Sing Optical R & D 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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- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
- YEASN — Chongqing Yeasn Science & Technology Co., Ltd. · Class I
- Medizs Auto Refractometer-Keratometer — MEDIZS Inc. · Class I
- AUTO REF/KERATO/TONOMETER — Nidek, Inc. · Class II
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
- Ningbo Ming Sing Optical R & D Co., Ltd.
Sources (1)
- FDA UDI 8200e49a-759e-4049-bfd2-aa96df0f71f2 34 fields · synced May 30, 2026