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TempaDOT 5192R

by Medical Indicators

TempaDOT 5192R (TD Plus F) is a Class I device made by Medical Indicators, registered in EUDAMED and listed in FDA GUDID since 29 May 2021 (UDI-DI 00016944301066), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00016944301066 UDI-DI Date29 May 2021ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 00016944301066 listed 29 May 2021 Listed

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
TempaDOT
Generic name
Colour-indication patient thermometer
Model / Ref / Catalog
5192R, TD Plus F
Primary DI / UDI-DI
00016944301066
FDA product code
FQZ
GMDN term
Colour-indication patient thermometer
Device class
Class I
Regulation number
880.2900
GUDID distribution status
In Commercial Distribution
Size
Weight — 0.0022 Pound

Similar devices

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

Other devices from Medical Indicators

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Properties

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