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Durasplint® Lc
EUDAMEDClass IIa (EU MDR)
Ref 3261Model Dental Bite Splint Material
Identity
- Trade Name
- DURASPLINT® LC EUDAMED
- Model / Reference
- Dental Bite Splint Material EUDAMED3261 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDEL32610 EUDAMED
- Basic UDI-DI
- ++EDELTD10BUDI010011DU EUDAMED
- Direct Marketing DI
- +EDEL32610 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL 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
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
Durasplint® Lc by DeltaMed GmbH — Class IIa — 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 | ++EDELTD10BUDI010011DU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (1)
- EUDAMED 27343008-5ec5-46de-8694-73b2639d015e 61 fields · synced Jul 21, 2026