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Duraliner II
EUDAMEDClass I (EU MDR)
Ref Duraliner II 4oz LiquidModel Duraliner II
Identity
- Trade Name
- Duraliner II EUDAMED
- Device Name
- Duraliner II 4oz Liquid EUDAMED
- Model / Reference
- Duraliner II EUDAMEDDuraliner II 4oz Liquid EUDAMED
Identifiers
- Primary DI / UDI-DI
- D9471603 EUDAMED
- Basic UDI-DI
- B-D9471603 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
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
Duraliner II by Reliance Dental Manufacturing — Class I — 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-D9471603 | 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 fab320ab-824b-4cc0-a677-b1230a8e18e6 61 fields · synced May 22, 2026