Optical Biometer

FDA UDI

Class II (US FDA UDI)

by Nidek, Inc.

Identity

Trade Name: OPTICAL BIOMETER FDA UDI
Generic Name: Ophthalmic examination slit lamp FDA UDI
Device Name: The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as corneal curvature radius and axial length. FDA UDI
Model / Reference: AL-Scan FDA UDI
Description: The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as corneal curvature radius and axial length. FDA UDI

Identifiers

Catalog Number: 39NNNN FDA UDI
Primary DI / UDI-DI: 04987669203477 FDA UDI
FDA Product Code: HJO FDA UDI
GMDN Term: Ophthalmic examination slit lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1850 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

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Premarket Exempt

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

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Manufacturing Date

FDA UDI

Category: Ophthalmic examination slit lamp Bench-top keratometer

Optical Biometer by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bench-top keratometer.

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OptochekPlus — REICHERT INC. · Class II
OPTICAL BIOMETER — SANTEC CORPORATION · Class II
Visionix — RIGHT MFG. CO., LTD. · Class I
WAVE ANALYZER MEDICA 700 PLUS — ESSILOR INTERNATIONAL · Class II
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 II	Pending data

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Manufacturer

Manufacturer: Nidek, Inc.

Sources (1)

FDA UDI afee5d99-7b32-4bfe-8dd3-972344756006 35 fields · synced May 30, 2026