FraiyaScan
by Fraiya Ltd United Kingdom EUDAMED
Ref FraiyaScan EMDN Z12080192
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberSCAR-4.2.1.1 | Date26 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- SCAR-4.2.1.1 Amended
Quality management system EU MDR
- Notified body
- Notified body 3022
- Issued
- 26 May 2026
- Expires
- 31 Jul 2030
- Reason
- Other
Specification
- Model / Reference
- FraiyaScan
- Primary DI / UDI-DI
- 05061081480018
- Basic UDI-DI
- 5061081485061081480001Q5
- Direct Marketing DI
- 05061081480018
- EMDN Code
- Z12080192 Prenatal diagnostic instruments - medical device software
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- UK-MF-000045978
- Authorised representative
- Obelis s.a. BE-AR-000000106
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 2dfd84fc-ef48-408d-b1bc-3c0fbfc7b10f