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Opaquer combo.lign Katalyst
EUDAMEDClass IIa (EU MDR)
Ref CO1X4KATModel Dental Crown and Bridge Materials and Accessories - Composite cements, Opaquer
Identity
- Trade Name
- Opaquer combo.lign Katalyst EUDAMED
- Model / Reference
- Dental Crown and Bridge Materials and Accessories - Composite cements, Opaquer EUDAMEDCO1X4KAT EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDELCO1X4KAT0 EUDAMED
- Basic UDI-DI
- ++EDELTD09BUDI010015MN EUDAMED
- Direct Marketing DI
- +EDELCO1X4KAT0 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 Katalyst 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 621920e2-c016-4e96-ab25-c893bcbb8133 61 fields · synced Jul 9, 2026