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Wondfo DW1-M

by Wondfo USA Co., Ltd.

Wondfo DW1-M is a Class II device made by Wondfo USA Co., Ltd., cleared under FDA 510(k) K043443 on 8 Apr 2005 and listed in FDA GUDID since 3 Jul 2025 (UDI-DI 00816862026801), active as of 22 Oct 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 22 Oct 2026

Documents

510(k) K043443

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816862026801 UDI-DI Date3 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK043443 Date8 Apr 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K043443 decided 8 Apr 2005 Active
  • FDA GUDID UDI-DI 00816862026801 listed 3 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K043443
  2. Listed FDA GUDID 00816862026801

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Wondfo
Generic name
Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Model / reference
DW1-M
Primary DI / UDI-DI
00816862026801
510(k) Number
FDA product code
LCX
GMDN term
Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Device class
Class II
Regulation number
862.1155
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

Cleared under the same submission (K043443)

and 8 more cleared under K043443

Similar devices

Other devices filed under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter).

Other devices from Wondfo USA Co., Ltd.

See all devices from Wondfo USA Co., Ltd. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)