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Endodontic obturation devices
EUDAMEDClass IIa (EU MDR)
Ref SRCH1000Model eHeater
Identity
- Trade Name
- Endodontic obturation devices EUDAMED
- Device Name
- Endodontic obturation devices EUDAMED
- Model / Reference
- eHeater EUDAMEDSRCH1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971075370401 EUDAMED
- Basic UDI-DI
- 697107537eHeaterWR 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Endodontic obturation devices by ChangZhou BoMedent Medical Technology Co., Ltd. — Class IIa — CE/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 | 697107537eHeaterWR | 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 (1)
- EUDAMED 960f0e68-692b-4c8b-8132-3c50c56b3a5d 61 fields · synced Oct 7, 2026