Identity
- Trade Name
- iNAP EUDAMED
- Device Name
- iNAP One Sleep Therapy System EUDAMED
- Model / Reference
- NP-R07-A EUDAMED91000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719878320962 EUDAMED
- Basic UDI-DI
- B-04719878320962 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iNAP by Somnics, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719878320962 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Somnics, Inc.
- EUDAMED SRN
- TW-MF-000009441
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 92f89a89-0a5c-490d-8baf-ae7b9833c6d2 61 fields · synced May 23, 2026