Identity
- Trade Name
- SleepRight EUDAMED
- Device Name
- SleepRight Secure-Comfort Dental Guard EUDAMED
- Model / Reference
- Secure-Comfort EUDAMED03205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10692121032052 EUDAMED
- Basic UDI-DI
- 69212103205MY EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL 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
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SleepRight by Splintek, Inc. — 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 | 69212103205MY | Class I | Active |
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Manufacturer
- Manufacturer
- Splintek, Inc.
- EUDAMED SRN
- US-MF-000012885
- Authorised Representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Sources (1)
- EUDAMED 097d18ec-71fd-4da4-8a22-ea5753569b8e 61 fields · synced May 23, 2026