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Alleset AGH4X250

by GRI Medical & Electronic Technology Co., Ltd.

Alleset AGH4X250 is a Class II device made by GRI Medical & Electronic Technology Co., Ltd., cleared under FDA 510(k) K242664 on 5 Nov 2024 and listed in FDA GUDID since 28 Oct 2026 (UDI-DI 16931918161877), active as of 9 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Nov 2026

Documents

510(k) K242664

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number16931918161877 UDI-DI Date28 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK242664 Date5 Nov 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242664 decided 5 Nov 2024 Active
  • FDA GUDID UDI-DI 16931918161877 listed 28 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K242664
  2. Listed FDA GUDID 16931918161877

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Alleset
Generic name
Blood lancet, single-use
Model / reference
AGH4X250
Primary DI / UDI-DI
16931918161877
510(k) Number
FDA product code
FMK
GMDN term
Blood lancet, single-use
Device class
Class II
Regulation number
878.4850
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K242664)

Other devices from GRI Medical & Electronic Technology Co., Ltd.

See all devices from GRI Medical & Electronic Technology Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)