Skip to content

TempTraq® TT-300

by Blue Spark Technologies, Inc.

Ref 631Model TT-300

TempTraq® TT-300 (631) is a device classified as Class IIa in the EU and Class II in the US made by Blue Spark Technologies, Inc., registered in EUDAMED on 17 Jul 2026 (Basic UDI-DI B-00851203006319), cleared under FDA 510(k) K201977 on 3 Dec 2020 and listed in FDA GUDID since 30 Jun 2023 (UDI-DI 00851203006319), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201977

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00851203006319 Basic UDI-DI 00851203006319UDI-DIDate17 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00851203006319 UDI-DI Date30 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK201977 Date3 Dec 2020IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00851203006319 registered 17 Jul 2026 Active
  • FDA 510(k) K201977 decided 3 Dec 2020 Active
  • FDA GUDID UDI-DI 00851203006319 listed 30 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201977
  2. Listed FDA GUDID 00851203006319
  3. Registered EUDAMED B-00851203006319

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
TempTraq®
Generic name
Wireless patient thermometer, single-use
Device name
TempTraq
Model / Ref / Catalog
TT-300, 631
Primary DI / UDI-DI
00851203006319
Basic UDI-DI
B-00851203006319
510(k) Number
FDA product code
FLL
EMDN code
V0301010201 Contact digital thermometers (including probes)
GMDN term
Wireless patient thermometer, single-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
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.

Related devices

Category: Wireless patient thermometer, single-use

Cleared under the same submission (K201977)

Similar devices in this category

Other devices filed under CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES).

Other devices from Blue Spark Technologies, Inc.

See all devices from Blue Spark Technologies, Inc. →

Properties

  • Single use
  • Measuring function
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)