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Medizs Auto Refractometer-Keratometer
FDA UDIClass I (US FDA UDI)
by MEDIZS Inc.
Identity
- Trade Name
- Medizs Auto Refractometer-Keratometer FDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- Medizs Auto Refractometer-Keratometer RK-11 is a refraction device to measure Both of Refractometry & Keratometry. And also, it is able to take patient's PD, Axis and Cylinder value for a prescription of vision correction. FDA UDI
- Model / Reference
- RK-11 FDA UDI
- Description
- Medizs Auto Refractometer-Keratometer RK-11 is a refraction device to measure Both of Refractometry & Keratometry. And also, it is able to take patient's PD, Axis and Cylinder value for a prescription of vision correction. FDA UDI
Identifiers
- Catalog Number
- RK-11 FDA UDI
- Primary DI / UDI-DI
- 08809358430291 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Automated ophthalmic refractometer
Medizs Auto Refractometer-Keratometer by MEDIZS Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automated ophthalmic refractometer.
- AUTO REFKERATOMETER — Tomey Corporation · Class I
- Visionix — RIGHT MFG. CO., LTD. · Class I
- YEASN — Chongqing Yeasn Science & Technology Co., Ltd. · Class I
- Tracey-VFA Visual Function Analyzer — Tracey Technologies, Corp. · Class I
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
- YEASN — Chongqing Yeasn Science & Technology Co., Ltd. · Class I
- AUTO REF/KERATO/TONOMETER — Nidek, Inc. · Class II
- Remidio — Remidio Innovative Solutions Private Limited · 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
- MEDIZS Inc.
Sources (1)
- FDA UDI 85525365-eb8d-45a7-81d7-2e70969c8660 34 fields · synced Jun 8, 2026