Identity
- Trade Name
- CLESTAⅡ EUDAMED
- Model / Reference
- CLESTAⅡ EUDAMEDAU-C2E-CR23GES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04952195410231 EUDAMED
- Basic UDI-DI
- 4952195AUTHE EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Clestaⅱ by Takara Belmont Corporation — 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 | 4952195AUTHE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Takara Belmont Corporation
- EUDAMED SRN
- JP-MF-000012052
- Authorised Representative
- Takara Company Europe GmbH DE-AR-000007799
Sources (1)
- EUDAMED 34f5c665-9068-4d9e-98a5-ddb535001ddd 61 fields · synced Jun 19, 2026