Skip to content

Finder 3409

by Baebies Inc.

Finder 3409 is a Class II device made by Baebies Inc., cleared under FDA 510(k) K201049 on 14 Sep 2022 and listed in FDA GUDID since 31 Jan 2025 (UDI-DI 00819704020333), active as of 23 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 23 Oct 2026

Documents

510(k) K201049

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00819704020333 UDI-DI Date31 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201049 Date14 Sep 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201049 decided 14 Sep 2022 Active
  • FDA GUDID UDI-DI 00819704020333 listed 31 Jan 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201049
  2. Listed FDA GUDID 00819704020333

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Finder
Generic name
Multiple clinical chemistry analyser IVD, point-of-care
Model / reference
3409
Primary DI / UDI-DI
00819704020333
510(k) Number
FDA product code
JBF
GMDN term
Multiple clinical chemistry analyser IVD, point-of-care
Device class
Class II
Regulation number
864.7360
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening).

Other devices from Baebies Inc.

See all devices from Baebies Inc. →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)