Identity
- Trade Name
- DD cubeY® HL 98H20 A3.5 EUDAMED
- Device Name
- DD medical zirconia EUDAMED
- Model / Reference
- 96316 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EDDI963161 EUDAMED
- Basic UDI-DI
- ++EDDIZIRCONIAIIBVT EUDAMED
- Unit of Use DI
- EDDI963169 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
DD cubeY® HL 98H20 A3.5 by Dental Direkt GmbH — Class IIb — 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 | ++EDDIZIRCONIAIIBVT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Dental Direkt GmbH
- EUDAMED SRN
- DE-MF-000006592
Sources (1)
- EUDAMED 9e0f4617-845b-4783-8438-4a6ca89554ad 61 fields · synced Jul 31, 2026