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DATEX Compatible Disposable SpO2 Sensor
EUDAMEDClass IIb (EU MDR)
Ref FMT-DIF/DTX-F
by Metko Medi̇kal Ve Tibbi̇ Ci̇hazlar Diş Ti̇caret Sanayi̇ Anoni̇m Şi̇rketi̇
Identity
- Trade Name
- DATEX Compatible Disposable SpO2 Sensor EUDAMED
- Device Name
- Sterile Pulse Oximetry (SpO2) Sensor EUDAMED
- Model / Reference
- FMT-DIF/DTX-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698870325150 EUDAMED
- Basic UDI-DI
- B-08698870325150 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
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
DATEX Compatible Disposable 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.
- APK — Apk Technology · Class II
- Spo2 sensor — Orantech Inc. · Class IIb
- MasimoSET® M-LNCS™ NeoPt SpO2 Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
- M-LNCS — MASIMO CORPORATION · Class II
- APK — Apk Technology · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- MasimoSET® LNCS® NeoPt Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
- MasimoSET® LNCS® NeoPt-3 SpO2 Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08698870325150 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022486
Sources (1)
- EUDAMED f4579d7d-6144-4d41-b894-e82b7ef30c5f 61 fields · synced Jul 27, 2026