← Back to catalogue
Clestaⅱ
EUDAMEDClass IIa (EU MDR)
Ref AU-C2E-CR230VCModel CLESTAⅡRef AU-C2E-CO230NCRef AU-C2E-CR23CESRef AU-C2E-CC230NCRef AU-C2E-CO23CES
Identity
- Trade Name
- CLESTAⅡ EUDAMED
- Model / Reference
- CLESTAⅡ EUDAMEDAU-C2E-CR230VC EUDAMEDAU-C2E-CO230NC EUDAMEDAU-C2E-CR23CES EUDAMEDAU-C2E-CC230NC EUDAMEDAU-C2E-CO23CES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04952195507801 EUDAMED04952195080632 EUDAMED04952195373239 EUDAMED04952195080571 EUDAMED04952195367788 EUDAMED
- Basic UDI-DI
- 4952195AUTHE EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania EUDAMEDItaly EUDAMEDGermany EUDAMEDRomania 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
Similar devices
Also classified as Dental delivery system.
- Dental Unit — Lifedent (Zhuhai) Co., Ltd. · Class IIa
- V8 TOUCH — VITALI S.R.L. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
- Forest — Ls Enterprises, Inc. · Class I
- TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
- Forest — Ls Enterprises, Inc. · Class I
- A5 SINGLE CART — CEFLA s.c. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Takara Belmont Corporation
- EUDAMED SRN
- JP-MF-000012052
- Authorised Representative
- Takara Company Europe GmbH DE-AR-000007799
Sources (5)
- EUDAMED 41bbd291-3f11-43ca-b30f-2516800dc523 61 fields · synced Jul 24, 2026
- EUDAMED e89574ec-17fe-49d0-81fa-1c0a65d6a425 61 fields · synced May 16, 2026
- EUDAMED 355cdbb2-db2f-485b-b733-0ecd2ebddcf4 61 fields · synced May 16, 2026
- EUDAMED cd8fe45c-79c0-4385-acb1-8b03f11e83ab 61 fields · synced May 16, 2026
- EUDAMED 0d046636-356e-41b3-aeb2-945ad88741ea 61 fields · synced May 18, 2026