Auto Ref/Kerato/Tonometer

FDA UDI

Class II (US FDA UDI)

by Nidek, Inc.

Identity

Trade Name: AUTO REF/KERATO/TONOMETER FDA UDI
Generic Name: Ophthalmic tonometer, line-powered FDA UDI
Device Name: AUTO REF/KERATO/TONOMETER Model TONOREF II is designed to singly perform objective refraction, corneal shape measurement, and non-contact tonometry measurement by incorporating a standard auto ref/keratometer and non-contact tonometer into one unit. The objective refraction function measures spherical powers, cylindrical powers and cylinder axis. The corneal shape measurement function measures the radius of corneal curvature (corneal refractive powers), the direction of the steepest meridian, and the amount of corneal astigmatism. The non-contact tonometry function measures the intraocular pressure without contacting the eye. FDA UDI
Model / Reference: TONOREF II FDA UDI
Description: AUTO REF/KERATO/TONOMETER Model TONOREF II is designed to singly perform objective refraction, corneal shape measurement, and non-contact tonometry measurement by incorporating a standard auto ref/keratometer and non-contact tonometer into one unit. The objective refraction function measures spherical powers, cylindrical powers and cylinder axis. The corneal shape measurement function measures the radius of corneal curvature (corneal refractive powers), the direction of the steepest meridian, and the amount of corneal astigmatism. The non-contact tonometry function measures the intraocular pressure without contacting the eye. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987669100066 FDA UDI
FDA Product Code: HKX FDA UDI
HKO FDA UDI
HLQ FDA UDI
GMDN Term: Ophthalmic tonometer, line-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1930 FDA UDI
886.1760 FDA UDI
886.1350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Automated ophthalmic refractometer Ophthalmic tonometer, line-powered Bench-top keratometer

Auto Ref/Kerato/Tonometer by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bench-top keratometer.

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OPTICAL BIOMETER — 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 II	Pending data

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Manufacturer

Manufacturer: Nidek, Inc.

Sources (1)

FDA UDI e208f396-dfbe-414e-9c05-6d6dcbc9a922 34 fields · synced Jun 8, 2026