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Reusable Soft SpO2 Sensor

by Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇ 213 variants

Ref FMT-RAS(B)/CHC-LR, FMT-RAS/CMN-LR, FMT-RPS/SIE-L, FMT-RAS(B)/NTG-LR, FMT-RAS/GLD-LL, FMT-RAS/MNM-L, FMT-RAS(B)/MRQ-L, FMT-RPS/MEK, FMT-RAS/CNC-LR, FMT-RAS(B)/MSD, FMT-RAS(B)/MND-LO, FMT-RAS/NON-L, FMT-RAS/MSD, FMT-RAS/MTN-L, FMT-RAS(B)/MRQ-LM, FMT-RAS/TRT-L, FMT-RAS(B)/DXT, FMT-RPS/NLO-L, FMT-RAS/OXY, FMT-RAS/GTG-LR, FMT-RPS/GOX-L, FMT-RAS(B)/IFM-L, FMT-RAS/RSD-L, FMT-RAS/SIE-LD, FMT-RPS/NLC, FMT-RAS(B)/DTS, FMT-RAS/AT-L, FMT-RAS/BRC-L, FMT-RAS/MEK, FMT-RAS/GLD-LR, FMT-RAS(B)/OHM-L, FMT-RAS(B)/GTG-LR, FMT-RPS/KNT-L, FMT-RAS(B)/MTN-LO, FMT-RAS/DTS, FMT-RAS(B)/AT-L, FMT-RAS/NVM, FMT-RAS(B)/MSM-L, FMT-RAS/MMH, FMT-RAS/BCI-L, FMT-RAS/UTS-L, FMT-RAS/NKN-L, FMT-RAS(B)/MEK-L, FMT-RAS/MND-L, FMT-RAS/HPS-L, FMT-RAS(B)/UTS-L, FMT-RAS(B)/MMH-L, FMT-RAS(B)/NTG, FMT-RAS(B)/MRQ-LO, FMT-RPS/DTX, FMT-RAS(B)/CNC-LR

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08698870362742 Basic UDI-DI Date14 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Non-Sterile Pulse Oximetry (SpO2) Sensor
Model / Reference
FMT-RAS(B)/CHC-LR, FMT-RAS/CMN-LR, FMT-RPS/SIE-L, FMT-RAS(B)/NTG-LR, FMT-RAS/GLD-LL, FMT-RAS/MNM-L, FMT-RAS(B)/MRQ-L, FMT-RPS/MEK, FMT-RAS/CNC-LR, FMT-RAS(B)/MSD, FMT-RAS(B)/MND-LO, FMT-RAS/NON-L, FMT-RAS/MSD, FMT-RAS/MTN-L, FMT-RAS(B)/MRQ-LM, FMT-RAS/TRT-L, FMT-RAS(B)/DXT, FMT-RPS/NLO-L, FMT-RAS/OXY, FMT-RAS/GTG-LR, FMT-RPS/GOX-L, FMT-RAS(B)/IFM-L, FMT-RAS/RSD-L, FMT-RAS/SIE-LD, FMT-RPS/NLC, FMT-RAS(B)/DTS, FMT-RAS/AT-L, FMT-RAS/BRC-L, FMT-RAS/MEK, FMT-RAS/GLD-LR, FMT-RAS(B)/OHM-L, FMT-RAS(B)/GTG-LR, FMT-RPS/KNT-L, FMT-RAS(B)/MTN-LO, FMT-RAS/DTS, FMT-RAS(B)/AT-L, FMT-RAS/NVM, FMT-RAS(B)/MSM-L, FMT-RAS/MMH, FMT-RAS/BCI-L, FMT-RAS/UTS-L, FMT-RAS/NKN-L, FMT-RAS(B)/MEK-L, FMT-RAS/MND-L, FMT-RAS/HPS-L, FMT-RAS(B)/UTS-L, FMT-RAS(B)/MMH-L, FMT-RAS(B)/NTG, FMT-RAS(B)/MRQ-LO, FMT-RPS/DTX, FMT-RAS(B)/CNC-LR
Primary DI / UDI-DI
08698870362742, 08698870374226, 08698870321732, 08698870363299, 08698870321244, 08698870324689, 08698870363107, 08698870321572, 08698870332400, 08698870370587, 08698870363077, 08698870330482, 08698870370570, 08698870370686, 08698870363114, 08698870370792, 08698870364296, 08698870324856, 08698870332110, 08698870341938, 08698870331144, 08698870370365, 08698870377258, 08698870378880, 08698870322296, 08698870362827, 08698870323248, 08698870322203, 08698870321565, 08698870321329, 08698870363329, 08698870362902, 08698870323491, 08698870379207, 08698870321404, 08698870362674, 08698870323088, 08698870363145, 08698870370464, 08698870321084, 08698870323880, 08698870321886, 08698870363008, 08698870324047, 08698870323729, 08698870363459, 08698870374486, 08698870363275, 08698870363121, 08698870322050, 08698870362759
Basic UDI-DI
B-08698870362742, B-08698870374226, B-08698870321732, B-08698870363299, B-08698870321244, B-08698870324689, B-08698870363107, B-08698870321572, B-08698870332400, B-08698870370587, B-08698870363077, B-08698870330482, B-08698870370570, B-08698870370686, B-08698870363114, B-08698870370792, B-08698870364296, B-08698870324856, B-08698870332110, B-08698870341938, B-08698870331144, B-08698870370365, B-08698870377258, B-08698870378880, B-08698870322296, B-08698870362827, B-08698870323248, B-08698870322203, B-08698870321565, B-08698870321329, B-08698870363329, B-08698870362902, B-08698870323491, B-08698870379207, B-08698870321404, B-08698870362674, B-08698870323088, B-08698870363145, B-08698870370464, B-08698870321084, B-08698870323880, B-08698870321886, B-08698870363008, B-08698870324047, B-08698870323729, B-08698870363459, B-08698870374486, B-08698870363275, B-08698870363121, B-08698870322050, B-08698870362759
EMDN Code
C900301 Pulse oximeter sensors
Device Class
Class IIb
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000022486

Related devices

Category: Pulse oximeter probe, single-use

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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