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Exergen TemporalScannerTM Thermometer

by Exergen Corporation EUDAMED

Active European Union

Ref 124375SModel TAT-5000S

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number083409800TAT5000SE3 Basic UDI-DIDate2 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000196658 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    30 Jul 2026
    Expires
    29 Jul 2031

Specification

EUDAMED

Device Name
Exergen TemporalScanner Thermometer TAT-5000S
Model / Reference
TAT-5000S, 124375S
Primary DI / UDI-DI
00834098001126
Basic UDI-DI
083409800TAT5000SE3
Direct Marketing DI
00834098001126
EMDN Code
V03010199 Thermometers - other
Device Class
Class IIa
Market of Registration
Germany

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

Show 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