Identity
- Trade Name
- ProSomnus EUDAMEDProsomnus IA Monogram FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- Basic obstructive sleep apnea devices EUDAMEDDevice for Obstructive Sleep Apnea iterative adjustment with patient comfort features FDA UDI
- Model / Reference
- [IA] EUDAMEDIA Monogram FDA UDI
- Description
- Device for Obstructive Sleep Apnea iterative adjustment with patient comfort features FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863039000416 EUDAMEDFDA UDI
- Basic UDI-DI
- 08630390004OSARW EUDAMED
- 510(k) Number
- K133683 FDA UDI
- FDA Product Code
- LRK 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ProSomnus by ProSomnus Sleep Technologies — Class I — 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 | 08630390004OSARW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ProSomnus Sleep Technologies
- EUDAMED SRN
- US-MF-000034424
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 9755b5ba-55ad-44df-982e-33cb424e3aff 61 fields · synced Oct 6, 2026
- FDA UDI bcfcde1c-8ef5-45a3-9ea1-f62f947718c1 34 fields · synced May 30, 2026