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Activity Sensor for Sleep/Wake detection
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SEN620Model Activity sensor
Identity
- Trade Name
- Activity Sensor for Sleep/Wake detection EUDAMEDFDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Model / Reference
- Activity sensor EUDAMEDSEN620 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250413400386 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134MovementEP EUDAMED
- 510(k) Number
- K071556 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
Activity Sensor for Sleep/Wake detection 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 | 42504134MovementEP | 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 1fcf84f8-22aa-4934-ac66-249fe3c7f535 61 fields · synced Jul 30, 2026
- FDA UDI 8e2dd2e1-ba7e-428f-ac64-1ad7e45ff1c9 33 fields · synced May 30, 2026