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Dr.Tempzone+ DR-TZ-US1

by One Power

Dr.Tempzone+ DR-TZ-US1 is a Class I device made by One Power, listed in FDA GUDID since 2 Nov 2020 (UDI-DI 08800105200037), 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 Number08800105200037 UDI-DI Date2 Nov 2020ListedStatusListed 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  • Withdrawn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
Dr.Tempzone+
Generic name
Colour-indication patient thermometer
Model / reference
DR-TZ-US1
Primary DI / UDI-DI
08800105200037
FDA product code
FQZ
GMDN term
Colour-indication patient thermometer
Device class
Class I
Regulation number
880.2900
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FQZ (Thermometer, Clinical Color Change).

Other devices from One Power

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)