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Spo2 sensors
EUDAMEDClass IIb (EU MDR)
Ref M48I10Model 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......... EUDAMEDM48I10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977191820165 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
Spo2 sensors by Med Accessories Technology DongGuan Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 a743da33-5f94-4c44-843a-e3b89b9266f5 61 fields · synced Jun 19, 2026