Identity
- Trade Name
- CLESTAⅡ EUDAMED
- Model / Reference
- CLESTAⅡ EUDAMEDAU-C2E-CO23GES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04952195367801 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
Category: Dental delivery system
Clestaⅱ by Takara Belmont Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 3b1015dc-0d81-4c12-a4bc-ddada0e48b0a 61 fields · synced Jun 18, 2026