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Duralay
EUDAMEDClass I (EU MDR)
Ref Duralay Laboratory Package ClearModel Duralay
Identity
- Trade Name
- Duralay EUDAMED
- Device Name
- Duralay EUDAMED
- Model / Reference
- Duralay EUDAMEDDuralay Laboratory Package Clear EUDAMED
Identifiers
- Primary DI / UDI-DI
- D9472249AC EUDAMED
- Basic UDI-DI
- ++D947DuralayB3 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Duralay by Reliance Dental Manufacturing — 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 | ++D947DuralayB3 | Class I | Active |
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Manufacturer
- Manufacturer
- Reliance Dental Manufacturing
- EUDAMED SRN
- US-MF-000041470
- Authorised Representative
- Kentzler-Kaschner Dental GmbH DE-AR-000006367
Sources (1)
- EUDAMED a9660b72-4fa8-4dbe-8104-dd2bebd4558c 61 fields · synced May 22, 2026