Identity
- Trade Name
- DUOnco Bone v1 EUDAMED
- Device Name
- DUOnco Bone EUDAMED
- Model / Reference
- DUOnco Bone v1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700719701102 EUDAMED
- Basic UDI-DI
- 37007197DUOncoBoneJJ EUDAMED
- Direct Marketing DI
- 03700719701102 EUDAMED
- EMDN Code
- Z11069082 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
DUOnco Bone v1 by Intrasense — 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 | 37007197DUOncoBoneJJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Intrasense
- EUDAMED SRN
- FR-MF-000001551
Sources (1)
- EUDAMED 290f3ae9-f5f3-410d-98a8-c097928113c4 61 fields · synced Jul 11, 2026