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Andesfit ADF-B38A

by Andesfit Limited

Andesfit ADF-B38A is a Class II device made by Andesfit Limited, listed in FDA GUDID since 15 Mar 2019 (UDI-DI 00146191203803), 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 Number00146191203803 UDI-DI Date15 Mar 2019ListedStatusListed 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  • Withdrawn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
Andesfit
Generic name
Infrared patient thermometer, skin
Model / reference
ADF-B38A
Primary DI / UDI-DI
00146191203803
FDA product code
FLL
GMDN term
Infrared patient thermometer, skin
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FLL (Thermometer, Electronic, Clinical).

Other devices from Andesfit Limited

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Properties

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