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BoneView
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref BoneViewModel BoneView / ChestView510(k) K212365
by Gleamer
Identity
- Trade Name
- BoneView EUDAMED
- Model / Reference
- BoneView / ChestView EUDAMEDBoneView EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770020839061 EUDAMED
- Basic UDI-DI
- 377002083900003AJ 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BoneView by Gleamer — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212365 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222176 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 377002083900003AJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gleamer
- EUDAMED SRN
- FR-MF-000011358
Sources (2)
- EUDAMED 2cd95a21-34ab-42d1-ba8f-fb9e6ba0cad8 85 fields · synced Jun 18, 2026
- FDA 510(k) K212365 1 fields · synced May 18, 2026