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KZR-CAD HR Block2 A2/L 5pcs
EUDAMEDClass IIa (EU MDR)
Ref KZR-CAD HR Block2Model Dental Resin
Identity
- Trade Name
- KZR-CAD HR Block2 A2/L 5pcs EUDAMED
- Device Name
- KZR-CAD HR Block 2 EUDAMED
- Model / Reference
- Dental Resin EUDAMEDKZR-CAD HR Block2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560231204852 EUDAMED
- Basic UDI-DI
- 456023117D10B101N001UG EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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 HR Block2 A2/L 5pcs 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 | 456023117D10B101N001UG | 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 62f778bb-ae5b-48ea-9aa7-e9631622f6aa 61 fields · synced Jul 11, 2026