BPCOmedia
Ref BPCOmedia
Active
CE MDR
Valid until
10 Jul 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805334084BPCOMEDISY 08053340840012 | Date7 Aug 2026 | StatusActive |
Certificates
- EPT 0477.MDR.25/5874 Active
Quality management system EU MDR
- Certifier
- Eurofins Product Testing Italy S.r.l. 0477
- Issued
- 11 Jul 2025
- Expires
- 10 Jul 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- BPCOmedia
- Primary DI / UDI-DI
- 08053340840012
- Basic UDI-DI
- 805334084BPCOMEDISY
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class IIa
- Special Device Type
- Software
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000039239
Properties
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