Identity
- Trade Name
- BoneCT EUDAMED
- Device Name
- LungCT/BoneCT EUDAMED
- Model / Reference
- BoneCT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770020839139 EUDAMED
- Basic UDI-DI
- 37700208390006L2 EUDAMED
- EMDN Code
- Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL 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
BoneCT by Gleamer — 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 | 37700208390006L2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gleamer
- EUDAMED SRN
- FR-MF-000011358
Sources (1)
- EUDAMED e01354ea-6ebb-4e2a-b3e6-1c3feff4ed50 61 fields · synced Jul 16, 2026