Pico Smart
Ref PICO SMART
Pico Smart is a Class IIb device made by Medica S.p.A., registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 803377232MPD-PSB3) with CE/MDR certificate MDR 00048-A valid until 31 May 2028, active as of 24 Oct 2026.
Active
CE MDR
Valid until
31 May 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number803377232MPD-PSB3 08033772329576 | Date17 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 803377232MPD-PSB3
Certificates
- MDR 00048-A Active
Quality management system EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 16 Apr 2026
- Expires
- 31 May 2028
Timeline
- Certificate issued EUDAMED MDR 00048-A
- Registered EUDAMED 803377232MPD-PSB3
- Certificate expires EUDAMED MDR 00048-A
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- PICO SMART
- Primary DI / UDI-DI
- 08033772329576
- Basic UDI-DI
- 803377232MPD-PSB3
- Direct marketing DI
- 08033772329576
- EMDN code
- Z12160401 Urodynamics systems
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000025691
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