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Dental root canal measuring and treatment units
EUDAMEDClass IIa (EU MDR)
Ref SRTA4000Model iRoot EcoRef SRTA3000Model Endo wise plus
Identity
- Trade Name
- Dental root canal measuring and treatment units EUDAMED
- Device Name
- Dental root canal measuring and treatment units EUDAMED
- Model / Reference
- iRoot Eco EUDAMEDSRTA4000 EUDAMEDEndo wise plus EUDAMEDSRTA3000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971075370326 EUDAMED06971075370319 EUDAMED
- Basic UDI-DI
- 697107537iRootEco35 EUDAMED697107537EndowiseplusYT 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
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental delivery system
Dental root canal measuring and treatment units by ChangZhou BoMedent Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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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 | 697107537iRootEco35 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ChangZhou BoMedent Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010413
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 9c5d7379-995d-4b30-9e3b-c17f89129b3e 61 fields · synced Oct 6, 2026
- EUDAMED f8e038f2-86fc-4ec6-b863-2201006f96be 61 fields · synced May 19, 2026