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ProSomnus EVO Sleep and Snore Device
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref EVO
Identity
- Trade Name
- ProSomnus EUDAMEDProSomnus EVO Sleep and Snore Device FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- Basic obstructive sleep apnea devices EUDAMED
- Model / Reference
- EVO EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863039000485 EUDAMEDFDA UDI
- Basic UDI-DI
- 08630390004OSARW EUDAMED
- 510(k) Number
- K202529 FDA UDI
- FDA Product Code
- LRK FDA UDILQZ FDA UDI
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5570 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ProSomnus EVO Sleep and Snore Device by ProSomnus Sleep Technologies — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ProSomnus Sleep Technologies
Sources (2)
- FDA UDI 76db6dd6-347f-441f-bd73-116033dc2290 33 fields · synced Oct 7, 2026
- EUDAMED 7e630f29-f0fd-4308-8080-4c9a2bc4ec34 61 fields · synced Jul 16, 2026