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Active PLM/EMG Sensor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SEN614Model PLM sensor
Identity
- Trade Name
- Active PLM/EMG Sensor EUDAMEDSOMNOscreen Plus accessory FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Model / Reference
- PLM sensor EUDAMEDSEN614 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250413400614 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134PLMSensor6L EUDAMED
- FDA Product Code
- MNR FDA UDIOLV 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 UDI882.1400 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
Yes
FDA UDI
Active PLM/EMG 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 | 42504134PLMSensor6L | 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 dd79b62d-b6d1-456b-81f8-835b8d397e7a 61 fields · synced Jul 9, 2026
- FDA UDI f128501a-6a5b-4c1e-993d-f8c0e515332e 32 fields · synced May 30, 2026