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Exergen TemporalScannerTM Thermometer

by Exergen Corporation United States EUDAMED

Ref 124005Model TAT-5000S

EMDN V03010199

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • 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 · synced 22 Oct 2026

Device Name
Exergen TemporalScanner Thermometer TAT-5000S
Model / Reference
TAT-5000S, 124005
Primary DI / UDI-DI
00834098000211
Basic UDI-DI
083409800TAT5000SE3
Direct Marketing DI
00834098000211
EMDN Code
V03010199 Thermometers - other
Device Class
Class IIa
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

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED a358cacd-084f-4040-9812-09d380ddf0db 61 fields · synced 22 Oct 2026