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KZR-CAD Zirconia Laxio GR-A1 φ98.5×t18
EUDAMEDClass IIa (EU MDR)
Ref KZR-CAD Zirconia LaxioModel Dental Porcelains
Identity
- Trade Name
- KZR-CAD Zirconia Laxio GR-A1 φ98.5×t18 EUDAMED
- Device Name
- KZR-CAD Zirconia Laxio EUDAMED
- Model / Reference
- Dental Porcelains EUDAMEDKZR-CAD Zirconia Laxio EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560231198519 EUDAMED
- Basic UDI-DI
- 456023117D12B102N001W9 EUDAMED
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
KZR-CAD Zirconia Laxio GR-A1 φ98.5×t18 by Yamakin Co., Ltd. — 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 | 456023117D12B102N001W9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Yamakin Co., Ltd.
- EUDAMED SRN
- JP-MF-000011382
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 0b362882-5b35-430a-a450-71a71bee1815 61 fields · synced Jun 18, 2026