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Reusable Wrap Soft SpO2 Sensor

EUDAMED

Class IIb (EU MDR)

Ref FMT-RNS/NLC-L

by Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇

Identity

Trade Name
Reusable Wrap Soft SpO2 Sensor EUDAMED
Device Name
Non-Sterile Pulse Oximetry (SpO2) Sensor EUDAMED
Model / Reference
FMT-RNS/NLC-L EUDAMED

Identifiers

Primary DI / UDI-DI
08698870322395 EUDAMED
Basic UDI-DI
B-08698870322395 EUDAMED
EMDN Code
C900301 PULSE OXIMETER SENSORS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Pulse oximeter probe, single-use

Reusable Wrap Soft SpO2 Sensor by Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇ — Class IIb — MDD — listed in EUDAMED

Similar devices

Also classified as Pulse oximeter probe, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇
EUDAMED SRN
TR-MF-000022486

Sources (1)

  • EUDAMED 01e0c715-949b-4981-8e76-9144daaefab5 61 fields · synced Jul 30, 2026