Identity
- Trade Name
- Snoreeze EUDAMED
- Device Name
- Snoring Relief Oral Device EUDAMED
- Model / Reference
- Version 2 EUDAMEDSMAN-BEN-001-V2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05035883010544 EUDAMED
- Basic UDI-DI
- 5035883SMAN4X EUDAMED
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Snoreeze by Passion For Life Healthcare (UK) Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5035883SMAN4X | Class I | Active |
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Manufacturer
- Manufacturer
- Passion For Life Healthcare (UK) Ltd
- EUDAMED SRN
- GB-MF-000004867
- Authorised Representative
- Passion For Life Healthcare (NL) B.V. NL-AR-000027672
Sources (1)
- EUDAMED 18deefd1-1e60-4e19-a85c-7808b26d9cb8 61 fields · synced Jun 18, 2026