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OPTICAL BIOMETER AL-Scan

by Nidek Co., Ltd. 2 variants

OPTICAL BIOMETER AL-Scan (39NNNN) is a Class II device made by Nidek Co., Ltd., listed in FDA GUDID since 12 Jun 2023 (UDI-DI 04987669203477), registry data as of 12 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04987669203477 UDI-DI Date12 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Optical Biometer
Generic name
Ophthalmic examination slit lamp
Model / Ref / Catalog
AL-Scan, 39NNNN
Primary DI / UDI-DI
04987669203477
FDA product code
HJO
GMDN term
Ophthalmic examination slit lamp
Device class
Class II
Regulation number
886.1850
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered).

Other devices from Nidek Co., Ltd.

  • NexLoad NP Toric

    Class IIb
  • NexLoad NP

    Class IIb
  • EyeCee ONE crystal preloaded

    Class IIb
  • EyeCee ONE preloaded

    Class IIb

See all devices from Nidek Co., Ltd. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)