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Exergen TemporalScannerTM Thermometer

by Exergen Corporation 14 variants

Ref 140001, 140023Model TAT-2000 and TAT-2000-EC

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

CE MDR

Valid until

29 Jul 2031

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000196658 Date30 Jul 2026IssuedStatusActive expires 29 Jul 2031
United StatesGUDID listing GUDID Number00834098002055 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Exergen TemporalScannerTM Thermometer EUDAMED
Exergen Temporal Scanner™ GUDID
Generic Name
Infrared patient thermometer, skin
Device Name
Exergen TemporalScanner Thermometer TAT-2000
Model / Ref / Catalog
TAT-2000 and TAT-2000-EC, 140001, 140023, TAT2000
Primary DI / UDI-DI
00834098002055 EUDAMED
10834098002052 GUDID
Basic UDI-DI
083409800TAT20007W
Direct Marketing DI
00834098002055
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 market of registration
Türkiye
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
TAT-2000 and TAT-2000-EC
140001, 140023
GUDID
TAT2000
Primary DI / UDI-DIEUDAMED
00834098002055
GUDID
10834098002052
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000011488
Authorised representative
Emergo Europe B.V. NL-AR-000000116

From the manufacturer

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

Other devices from Exergen Corporation

See all devices from Exergen Corporation →

Properties

  • Measuring Function
  • Over-the-Counter
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No