FloyMammo
by Floy GmbH Germany EUDAMED
Ref FloyMammo
EMDN Z11030592
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberSCAR-7.2.1.5 | Date21 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- SCAR-7.2.1.5 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 3022
- Issued
- 21 Aug 2026
- Expires
- 29 Sep 2030
- Reason
- Other
Specification
- Model / Reference
- FloyMammo
- Primary DI / UDI-DI
- 04260761040349
- Basic UDI-DI
- 426076104FLOYMAMMOEX
- Direct Marketing DI
- 04260761040349
- EMDN Code
- Z11030592 Radiology instruments - medical device software
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000016503
Other devices from Floy GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 93235310-504a-44cd-8d9d-0a0f1c996f3a