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Somté PSG
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 9023-0002-01Model Somté PSG v2 System, No software510(k) K021176
Identity
- Trade Name
- Compumedics Somte FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Somté PSG EUDAMEDSomte PSG v2 System, No software FDA UDI
- Model / Reference
- Somté PSG v2 System, No software EUDAMED9023-0002-01 EUDAMEDSomte PSG v2 FDA UDI
- Description
- Somte PSG v2 System, No software FDA UDI
Identifiers
- Catalog Number
- 9023-0002-01 FDA UDI
- Primary DI / UDI-DI
- 09342451001368 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09342451001368 EUDAMED
- 510(k) Number
- K072201 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Somté PSG by Compumedics Limited — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K021176 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-09342451001368 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Compumedics Limited
- EUDAMED SRN
- AU-MF-000050437
- Authorised Representative
- Compumedics EUROPE GmbH DE-AR-000039096
Sources (3)
- EUDAMED 6abb9e59-f0c9-4540-84e7-b3fcc6ac949a 85 fields · synced Jun 18, 2026
- FDA UDI c869bf32-17f3-471f-947a-bee7179aaf0b 37 fields · synced May 30, 2026
- FDA 510(k) K021176 1 fields · synced May 18, 2026