Identity
- Trade Name
- AUTO REF/KERATOMETER FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis. RM-9600 Measuring fuction include refractive measurement. RM-9600 Auto refractometer Fashionable design and perfect in details Equipped with ARM Cortex-A8 processor, facilitating fast calculations Upgraded refractive and keratometry measurement technique, providing more comprehensive image analyzing Electric chin rest lifting, automatic tracing and focusing(Y axis) provides more intellectual operation 7 inch touch screen with adjustable angle and ergonomic structure design FDA UDI
- Model / Reference
- RM-9600 FDA UDI
- Description
- This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis. RM-9600 Measuring fuction include refractive measurement. RM-9600 Auto refractometer Fashionable design and perfect in details Equipped with ARM Cortex-A8 processor, facilitating fast calculations Upgraded refractive and keratometry measurement technique, providing more comprehensive image analyzing Electric chin rest lifting, automatic tracing and focusing(Y axis) provides more intellectual operation 7 inch touch screen with adjustable angle and ergonomic structure design FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971821402073 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
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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
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- 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 20783454-d49f-463d-9c1b-1f67d22fe124 34 fields · synced May 30, 2026