MammoScreen
Ref MAML
MammoScreen (MAML) is a medical device (EU MDD Class IIa) made by Therapixel SA, registered in EUDAMED on 30 Apr 2025 (Basic UDI-DI B-+B885MAML0) and cleared under FDA 510(k) K192854 on 25 Mar 2020, active as of 24 Oct 2026.
Active
CE MDD 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-+B885MAML0 | Date30 Apr 2025 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK192854 | Date25 Mar 2020 | StatusActive |
Official records
- EUDAMED public site B-+B885MAML0
- FDA 510(k) database K192854
Across registries
- EUDAMED Basic UDI-DI B-+B885MAML0 registered 30 Apr 2025 Active
- FDA 510(k) K192854 decided 25 Mar 2020 Active
Timeline
- Cleared FDA 510(k) K192854
- Registered EUDAMED B-+B885MAML0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Model / reference
- MAML
- Primary DI / UDI-DI
- +B885MAML0, +B885MAML2EU0
- Basic UDI-DI
- B-+B885MAML0, ++B885MAMMOSCREENQB
- EMDN code
- Z11030282, Z11030292
- Device class
- Class IIa
- Special device type
- Software
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- FranceBelgium
Manufacturer details
- EUDAMED SRN
- FR-MF-000035499
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