Skip to content

TempaDOT, C Sterile

by Medical Indicators

Ref 5532

TempaDOT, C Sterile (5532) is a Class I device made by Medical Indicators, registered in EUDAMED on 20 Mar 2024 (Basic UDI-DI 016944TDsterileEC) and listed in FDA GUDID since 29 May 2021 (UDI-DI 00016944301080), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number016944TDsterileEC Basic UDI-DI 00016944301080UDI-DIDate20 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00016944301080 UDI-DI Date29 May 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 016944TDsterileEC registered 20 Mar 2024 Active
  • FDA GUDID UDI-DI 00016944301080 listed 29 May 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00016944301080
  2. Registered EUDAMED 016944TDsterileEC

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  • Withdrawn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, C Sterile EUDAMED
TempaDOT GUDID
Generic name
Colour-indication patient thermometer
Model / Ref / Catalog
5532, TD Sterile C
Primary DI / UDI-DI
00016944301080
Basic UDI-DI
016944TDsterileEC
Unit of use DI
10016944301087
FDA product code
FQZ
EMDN code
V03010199 Thermometers - other
GMDN term
Colour-indication patient thermometer
Device class
Class I
Regulation number
880.2900
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization
Size
Weight — 0.00143 Pound

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00016944301080: EUDAMED states No, FDA GUDID states Yes.

Manufacturer details

EUDAMED SRN
US-MF-000018094
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under THERMOMETERS - OTHER.

Other devices from Medical Indicators

See all devices from Medical Indicators →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Measuring function
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)