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Exergen Temporal Scanner TAT2000C

by Exergen Corporation

Ref 140008Model TAT-2000C and TAT-2000C-EC

Exergen Temporal Scanner TAT2000C (140008) is a device classified as Class IIa in the EU and Class II in the US made by Exergen Corporation, registered in EUDAMED on 13 Oct 2025 (Basic UDI-DI 083409800TAT2000CC2) with CE/MDR certificate 1000196658 valid until 29 Jul 2031, cleared under FDA 510(k) K011291 on 12 Jul 2001 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00834098002062), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

29 Jul 2031

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

510(k) K011291

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000196658 Date30 Jul 2026IssuedStatusActive expires 29 Jul 2031
United StatesGUDID listing GUDID Number00834098002062 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK011291 Date12 Jul 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 083409800TAT2000CC2 registered 13 Oct 2025 Active· +1 more in the status table
  • FDA 510(k) K011291 decided 12 Jul 2001 Active
  • FDA GUDID UDI-DI 00834098002062 listed 24 Sep 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000196658 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    30 Jul 2026
    Expires
    29 Jul 2031

Timeline

5 dated events

  1. Cleared FDA 510(k) K011291
  2. Listed FDA GUDID 00834098002062
  3. Registered EUDAMED 083409800TAT2000CC2
  4. Certificate issued EUDAMED 1000196658
  5. Certificate expires EUDAMED 1000196658

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Exergen TemporalScannerTM Thermometer EUDAMED
Exergen Temporal Scanner GUDID
Generic name
Infrared patient thermometer, skin
Device name
Exergen TemporalScanner Thermometer TAT-2000C
Model / Ref / Catalog
TAT-2000C and TAT-2000C-EC, 140008, TAT2000C
Primary DI / UDI-DI
00834098002062
Basic UDI-DI
083409800TAT2000CC2
Direct marketing DI
00834098002062
510(k) Number
FDA product code
FLL
EMDN code
V03010199 Thermometers - other
GMDN term
Infrared patient thermometer, skin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.2910
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TAT-2000C and TAT-2000C-EC
140008
GUDID
TAT2000C
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.

From the manufacturer

Manufacturer's product page: Exergen Corporation Receives the Regulatory Approval to Launch the Full Line of Temporal Artery Thermometers in Peru

Related devices

Cleared under the same submission (K011291)

and 8 more cleared under K011291

Similar devices in this category

Other devices filed under THERMOMETERS - OTHER.

Other devices from Exergen Corporation

See all devices from Exergen Corporation →

Properties

  • Measuring function
  • Over-the-counter
  • Lot / batch number
Other properties (22, all answered No)