Identity
- Trade Name
- BreastView EUDAMED
- Device Name
- BreastView EUDAMED
- Model / Reference
- BreastView EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770020839115 EUDAMED
- Basic UDI-DI
- 377002083900004AL 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
BreastView 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 | 377002083900004AL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gleamer
- EUDAMED SRN
- FR-MF-000011358
Sources (1)
- EUDAMED c9542646-1617-4f67-b6f9-29f45cafc62c 61 fields · synced Jun 19, 2026