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Reusable Esophageal / Rectal Temperature Probe

by Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇ EUDAMED

Active European Union

Ref FMT400/AOR/MND-A15, FMT400/IOR-15, FMT400/POR/Z, FMT400/AOR/EDN-A, FMT400/AOR/GH-A15, FMT400/POR/EDN/Z-A, FMT400/AOR/Z-A, FMT400/AOR/THT, FMT400/AOR/HP, FMT400/POR/HP-15, FMT400/POR/GH-A, FMT400/POR/Z-A15, FMT400/IOR/S-15, FMT400/AOR/HP-A, FMT400/AOR/EDN/Z-A15, FMT400/AOR/MND-15, FMT400/IOR/S, FMT400/AOR/GE, FMT400/AOR/EDN, FMT400/IOR/SW-15, FMT400/AOR/EDN/Z-A, Reusable Esophageal / Rectal Temperature Probe, FMT400/AOR/S-A15, FMT400/POR-15, FMT400/POR/GH-15, FMT400/AOR/EDN-A15, FMT400/AOR/HP-15, FMT400/POR, FMT400/AOR/GH, FMT400/IOR/HP-15, FMT400/POR-A, FMT400/AOR/EDN/Z, FMT400/IOR, FMT400/POR/MND-15, FMT400/POR/EDN/Z-A15, FMT400/POR/S-15, FMT400/AOR/S, FMT400/POR/GE, FMT400/POR/HP, FMT400/AOR/Z-A15, FMT400/POR-A15, FMT400/POR/SW-15, FMT400/IOR/Z-15, FMT400/IOR/MND, FMT400/AOR/GE-15, FMT400/AOR-A, FMT400/AOR, FMT400/AOR/MND, FMT400/POR/EDN-A, FMT400/IOR/SW, FMT400/IOR/HPModel FMT400/POR/GH-A15

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08698870355348 Basic UDI-DIDate13 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Non-Sterile Medical Temperature Probe
Model / Reference
FMT400/AOR/MND-A15, FMT400/IOR-15, FMT400/POR/Z, FMT400/AOR/EDN-A, FMT400/AOR/GH-A15, FMT400/POR/EDN/Z-A, FMT400/AOR/Z-A, FMT400/AOR/THT, FMT400/AOR/HP, FMT400/POR/HP-15, FMT400/POR/GH-A, FMT400/POR/Z-A15, FMT400/IOR/S-15, FMT400/AOR/HP-A, FMT400/AOR/EDN/Z-A15, FMT400/AOR/MND-15, FMT400/IOR/S, FMT400/AOR/GE, FMT400/AOR/EDN, FMT400/IOR/SW-15, FMT400/AOR/EDN/Z-A, FMT400/POR/GH-A15, Reusable Esophageal / Rectal Temperature Probe, FMT400/AOR/S-A15, FMT400/POR-15, FMT400/POR/GH-15, FMT400/AOR/EDN-A15, FMT400/AOR/HP-15, FMT400/POR, FMT400/AOR/GH, FMT400/IOR/HP-15, FMT400/POR-A, FMT400/AOR/EDN/Z, FMT400/IOR, FMT400/POR/MND-15, FMT400/POR/EDN/Z-A15, FMT400/POR/S-15, FMT400/AOR/S, FMT400/POR/GE, FMT400/POR/HP, FMT400/AOR/Z-A15, FMT400/POR-A15, FMT400/POR/SW-15, FMT400/IOR/Z-15, FMT400/IOR/MND, FMT400/AOR/GE-15, FMT400/AOR-A, FMT400/AOR, FMT400/AOR/MND, FMT400/POR/EDN-A, FMT400/IOR/SW, FMT400/IOR/HP
Primary DI / UDI-DI
08698870355348, 08698870373250, 08698870359872, 08698870365576, 08698870378392, 08698870369017, 08698870359803, 08698870368881, 08698870325402, 08698870335296, 08698870378293, 08698870359780, 08698870378071, 08698870325525, 08698870368980, 08698870355287, 08698870376282, 08698870330949, 08698870365514, 08698870378002, 08698870368973, 08698870378408, 08698870325556, 08698870335272, 08698870378378, 08698870365583, 08698870325419, 08698870335265, 08698870378330, 08698870378088, 08698870335364, 08698870368959, 08698870373243, 08698870355324, 08698870369024, 08698870335319, 08698870325426, 08698870335340, 08698870335289, 08698870359810, 08698870335371, 08698870335333, 08698870373274, 08698870378033, 08698870330970, 08698870325501, 08698870325389, 08698870355270, 08698870365590, 08698870377999, 08698870376299
Basic UDI-DI
B-08698870355348, B-08698870373250, B-08698870359872, B-08698870365576, B-08698870378392, B-08698870369017, B-08698870359803, B-08698870368881, B-08698870325402, B-08698870335296, B-08698870378293, B-08698870359780, B-08698870378071, B-08698870325525, B-08698870368980, B-08698870355287, B-08698870376282, B-08698870330949, B-08698870365514, B-08698870378002, B-08698870368973, B-08698870378408, B-08698870325556, B-08698870335272, B-08698870378378, B-08698870365583, B-08698870325419, B-08698870335265, B-08698870378330, B-08698870378088, B-08698870335364, B-08698870368959, B-08698870373243, B-08698870355324, B-08698870369024, B-08698870335319, B-08698870325426, B-08698870335340, B-08698870335289, B-08698870359810, B-08698870335371, B-08698870335333, B-08698870373274, B-08698870378033, B-08698870330970, B-08698870325501, B-08698870325389, B-08698870355270, B-08698870365590, B-08698870377999, B-08698870376299
EMDN Code
V03010299 Body temperature monitoring probes - other
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000022486

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Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No