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crea.lign Opaker 8 A4/C4
EUDAMEDClass IIa (EU MDR)
Ref CLFHOP08Model Dental Crown and Bridge Materials and Accessories - Composite Paste, Flowable Composite, Opaquer
Identity
- Trade Name
- crea.lign Opaker 8 A4/C4 EUDAMED
- Model / Reference
- Dental Crown and Bridge Materials and Accessories - Composite Paste, Flowable Composite, Opaquer EUDAMEDCLFHOP08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDELCLFHOP080 EUDAMED
- Basic UDI-DI
- ++EDELTD09BUDI030017NG EUDAMED
- Direct Marketing DI
- +EDELCLFHOP080 EUDAMED
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
crea.lign Opaker 8 A4/C4 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 | ++EDELTD09BUDI030017NG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (1)
- EUDAMED b8d19c77-344c-4eb0-b252-8a6531ef0e5a 61 fields · synced Jul 9, 2026