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TempTraq

by Blue Spark Technologies, Inc. 29 variants

TempTraq is a wireless patient monitor/sensor reporting software (EU MDD Class IIa; FDA Class II; FDA product code FLL, Thermometer, Electronic, Clinical) made by Blue Spark Technologies, Inc., registered in EUDAMED on 27 Sep 2022 (Basic UDI-DI B-00851203006043) and listed in FDA GUDID since 26 Aug 2016 (UDI-DI 00851203006043), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

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/MDD EUDAMED NumberB-00851203006043 Basic UDI-DI 00851203006043UDI-DIDate27 Sep 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00851203006043 UDI-DI Date26 Aug 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00851203006043 registered 27 Sep 2022 Active
  • FDA GUDID UDI-DI 00851203006043 listed 26 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00851203006043
  2. Registered EUDAMED B-00851203006043

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Wireless patient monitor/sensor reporting software, layperson-use
Model / reference
TempTraq Consumer iOS App
Primary DI / UDI-DI
00851203006043
Basic UDI-DI
B-00851203006043
FDA product code
FLL
EMDN code
V92 Medical device software - not included in other classes
GMDN term
Wireless patient monitor/sensor reporting software, layperson-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.2910
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000026609
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES.

Other devices from Blue Spark Technologies, Inc.

See all devices from Blue Spark Technologies, Inc. →

Properties

  • Measuring function
  • Over-the-counter
  • Lot / batch number
Other properties (20, all answered No)