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Spo2 sensors
EUDAMEDClass IIb (EU MDR)
Ref M48A10SModel M48A10,M48P105,M05A105,M121A10,M15P10S,M48N10,M42DA03,M91P10S,M125A03S,M21PA10,M01PO3S,M02N03M02A03,M06P03S,M137A10S,M49A10.........
Identity
- Device Name
- Spo2 sensors EUDAMED
- Model / Reference
- M48A10,M48P105,M05A105,M121A10,M15P10S,M48N10,M42DA03,M91P10S,M125A03S,M21PA10,M01PO3S,M02N03M02A03,M06P03S,M137A10S,M49A10......... EUDAMEDM48A10S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977191820042 EUDAMED
- Basic UDI-DI
- 697719182Spo202C8 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulse oximeter probe, single-use
Spo2 sensors by Med Accessories Technology DongGuan Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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
- Reusable Soft SpO2 Sensor — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class IIb
- 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
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697719182Spo202C8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Med Accessories Technology DongGuan Co., Ltd.
- EUDAMED SRN
- CN-MF-000037840
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ea871e95-1f9b-4139-8671-a2b3dd8d5a0d 61 fields · synced Jun 18, 2026