Identity
- Device Name
- MammoScape EUDAMED
- Model / Reference
- 1.x EUDAMEDEIRA-1.1.4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260483290312 EUDAMED
- Basic UDI-DI
- 0426048329EIRAT6 EUDAMED
- Direct Marketing DI
- 04260483290312 EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
MammoScape by Mevis Medical Solutions Ag — 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 | 0426048329EIRAT6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MeVis Medical Solutions AG
- EUDAMED SRN
- DE-MF-000005418
Sources (1)
- EUDAMED 981cae8a-ebe5-4880-91fd-8f970e0f1b95 61 fields · synced Jun 19, 2026