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Soft Silicone Finger Sensor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TOS060Model SpO2 sensor
Identity
- Trade Name
- Soft Silicone Finger Sensor EUDAMEDSOMNOtouch RESP Accessory FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Model / Reference
- SpO2 sensor EUDAMEDTOS060 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250413404322 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134FC4Z EUDAMED
- 510(k) Number
- K140861 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Soft Silicone Finger Sensor by SOMNOmedics AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504134FC4Z | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (2)
- EUDAMED 38b5463e-d2e5-4f46-83fc-dc83f99f5963 61 fields · synced Jun 19, 2026
- FDA UDI c024adc7-04e0-463e-a9fd-16a62930bb71 33 fields · synced May 29, 2026