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SoftWrap Finger Sensor
EUDAMEDClass IIa (EU MDR)
Ref TOS070Model SpO2 sensorRef TOS071
Identity
- Trade Name
- SoftWrap Finger Sensor EUDAMED
- Model / Reference
- SpO2 sensor EUDAMEDTOS070 EUDAMEDTOS071 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413404346 EUDAMED04250413405053 EUDAMED
- Basic UDI-DI
- 42504134FC4Z EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
SoftWrap Finger Sensor by SOMNOmedics AG — Class IIa — 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 | 42504134FC4Z | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED 6199fc33-60e5-43f8-ba44-7ac59b920662 61 fields · synced Jul 30, 2026
- EUDAMED 4fd962fb-c717-471b-8a4f-823975a24303 61 fields · synced May 19, 2026