AUTO REFRACTOMETER - The AUTO REFRACTOMETER AR-F is a medical device - NIDEK CO.,LTD.

Duns Number:690635461

Device Description: The AUTO REFRACTOMETER AR-F is a medical device which measures objective refractive errors The AUTO REFRACTOMETER AR-F is a medical device which measures objective refractive errors of the patient’s eye. This device also offers retroillumination mode for observing the condition of the ocular media, and measures the amplitude of accommodation.

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More Product Details

Catalog Number

-

Brand Name

AUTO REFRACTOMETER

Version/Model Number

AR-F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HKO

Product Code Name

Refractometer, Ophthalmic

Device Record Status

Public Device Record Key

7b6312f2-a0a9-4753-bb57-3b77a0a92b3e

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

February 22, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NIDEK CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 39
2 A medical device with a moderate to high risk that requires special controls. 73
3 A medical device with high risk that requires premarket approval 5