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Launch TAE03-12S

by Shenzhen Launch Electrical Co., Ltd

Launch TAE03-12S is a Class II device made by Shenzhen Launch Electrical Co., Ltd, cleared under FDA 510(k) K181967 on 10 Dec 2018 and listed in FDA GUDID since 2 Sep 2019 (UDI-DI 06947437960092), 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) K181967

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 Number06947437960092 UDI-DI Date2 Sep 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181967 Date10 Dec 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181967 decided 10 Dec 2018 Active
  • FDA GUDID UDI-DI 06947437960092 listed 2 Sep 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181967
  2. Listed FDA GUDID 06947437960092

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Launch
Generic name
General-purpose patient temperature probe, single-use
Model / reference
TAE03-12S
Primary DI / UDI-DI
06947437960092
510(k) Number
FDA product code
FLL
GMDN term
General-purpose patient temperature probe, single-use
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under General-purpose patient temperature probe, single-use.

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Properties

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