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CPAP Pressure Sensor (+/- 36 mbar)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SEN633Model CPAP sensor
Identity
- Trade Name
- CPAP Pressure Sensor (+/- 36 mbar) EUDAMEDSOMNOscreen plus Accessory FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Model / Reference
- CPAP sensor EUDAMEDSEN633 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250413400218 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134CPAP-senN2 EUDAMED
- 510(k) Number
- K081485 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12159008 PNEUMOTACHOGRAPHS 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
CPAP Pressure Sensor (+/- 36 mbar) 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 | 42504134CPAP-senN2 | 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 846b1588-6b01-4819-92c2-4dcd5e024803 61 fields · synced Jul 15, 2026
- FDA UDI da9e0adc-823e-4ffd-b48a-a86c1936fccd 33 fields · synced May 29, 2026