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MammoScreen
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref MAML510(k) K192854
by Therapixel
Identity
- Trade Name
- MammoScreen EUDAMED
- Device Name
- MammoScreen EUDAMED
- Model / Reference
- MAML EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B885MAML0 EUDAMED
- Basic UDI-DI
- B-+B885MAML0 EUDAMED
- EMDN Code
- Z11030282 MAMMOGRAPHY SYSTEMS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MammoScreen by Therapixel — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192854 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-+B885MAML0 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Therapixel
- EUDAMED SRN
- FR-MF-000035499
Sources (2)
- EUDAMED 55a77be4-1cd7-4c71-a85a-968a8fa2d93e 85 fields · synced Jun 18, 2026
- FDA 510(k) K192854 1 fields · synced May 18, 2026