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L8-17H

by Alpinion Medical Systems Co., Ltd.

L8-17H is a Class II device made by Alpinion Medical Systems Co., Ltd., listed in FDA GUDID since 29 May 2026 (UDI-DI 08800013510112), registry data as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800013510112 UDI-DI Date29 May 2026ListedStatusListed 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  • Withdrawn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

Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Model / reference
L8-17H
Primary DI / UDI-DI
08800013510112
FDA product code
ITX, IYO, IYN
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class II
Regulation number
892.1570, 892.1560, 892.1550
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

Other devices from Alpinion Medical Systems Co., Ltd.

  • L3-8

    Class II

  • SP4-12

    Class II

  • L3-12H

    Class II

  • E3-10H

    Class II

See all devices from Alpinion Medical Systems Co., Ltd. →

Properties

  • Serial number
Other properties (14, all answered No)