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Exergen TemporalScannerTM Thermometer

by Exergen Corporation 32 variants

Ref 124399Model TAT-5000S

Active European Union

CE MDR

Valid until

29 Jul 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000196658 Date30 Jul 2026IssuedStatusActive expires 29 Jul 2031

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Exergen TemporalScanner Thermometer TAT-5000S
Model / Reference
TAT-5000S, 124399
Primary DI / UDI-DI
00834098001232
Basic UDI-DI
083409800TAT5000SE3
Direct Marketing DI
00834098001232
EMDN Code
V03010199 Thermometers - other
Device Class
Class IIa
EU market of registration
Denmark

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

Other properties (12)

  • Sterile: 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