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Caremed TZDHP-PH

by Shenzhen Caremed Medical Technology Co., Ltd.

Caremed TZDHP-PH is a Class II device made by Shenzhen Caremed Medical Technology Co., Ltd., cleared under FDA 510(k) K182751 on 6 Sep 2019 and listed in FDA GUDID since 1 Nov 2019 (UDI-DI 06970758507721), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K182751

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 Number06970758507721 UDI-DI Date1 Nov 2019ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182751 Date6 Sep 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182751 decided 6 Sep 2019 Active
  • FDA GUDID UDI-DI 06970758507721 listed 1 Nov 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182751
  2. Listed FDA GUDID 06970758507721

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Caremed
Generic name
General-purpose patient temperature probe, reusable
Model / Ref / Catalog
TZDHP-PH
Primary DI / UDI-DI
06970758507721
510(k) Number
FDA product code
FLL
GMDN term
General-purpose patient temperature probe, reusable
Device class
Class II
Regulation number
880.2910
GUDID distribution status
Not in Commercial Distribution

Similar devices

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

Other devices from Shenzhen Caremed Medical Technology Co., Ltd.

See all devices from Shenzhen Caremed Medical Technology Co., Ltd. →

Properties

  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)