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Opaquer combo.lign medium
EUDAMEDClass IIa (EU MDR)
Ref CO1X4OPMModel Dental Crown and Bridge Materials and Accessories - Composite cements, Opaquer
Identity
- Trade Name
- Opaquer combo.lign medium EUDAMED
- Model / Reference
- Dental Crown and Bridge Materials and Accessories - Composite cements, Opaquer EUDAMEDCO1X4OPM EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDELCO1X4OPM0 EUDAMED
- Basic UDI-DI
- ++EDELTD09BUDI010015MN EUDAMED
- Direct Marketing DI
- +EDELCO1X4OPM0 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
Opaquer combo.lign medium 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 | ++EDELTD09BUDI010015MN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (1)
- EUDAMED b56d8727-e508-4582-960a-2cc63e565c15 61 fields · synced Jul 16, 2026