Identity
- Trade Name
- BonSensor EUDAMED
- Device Name
- Digital ntraoral X-Ray Imaging System EUDAMED
- Model / Reference
- Bon0015X EUDAMEDDR2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974600260482 EUDAMED
- Basic UDI-DI
- 697460026intraloralDRWU EUDAMED
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
BonSensor by Changzhou Boen Zhongding Medical Technology Co., Ltd. — 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 | 697460026intraloralDRWU | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000021444
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 6163938a-ee1d-4f44-b7f4-dc9daec2b645 61 fields · synced Jun 18, 2026