Restore Plus Dcb
by Cardionovum GmbH 39 variants
Ref RP 2.25-30
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05906190154149 05906190154149 | Date24 Aug 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
EU market availability
Made available in 32 countries, as listed in EUDAMED:
- Austria since 24 May 2021
- Belgium since 24 May 2021
- Bulgaria since 24 May 2021
- Croatia since 24 May 2021
- Cyprus since 24 May 2021
- Czechia since 24 May 2021
- Denmark since 24 May 2021
- Estonia since 24 May 2021
- Finland since 24 May 2021
- France since 24 May 2021
- Germany since 24 May 2021
- Greece since 24 May 2021
- Hungary since 24 May 2021
- Iceland since 24 May 2021
- Ireland since 24 May 2021
- Italy since 24 May 2021
- Latvia since 24 May 2021
- Liechtenstein since 24 May 2021
- Lithuania since 24 May 2021
- Luxembourg since 24 May 2021
- Malta since 24 May 2021
- Netherlands since 24 May 2021
- Northern Ireland since 24 May 2021
- Norway since 24 May 2021
- Poland since 24 May 2021
- Portugal since 24 May 2021
- Romania since 24 May 2021
- Slovakia since 24 May 2021
- Slovenia since 24 May 2021
- Spain since 24 May 2021
- Sweden since 24 May 2021
- Türkiye since 24 May 2021
Specification
- Device Name
- RESTORE PLUS DCB Paclitaxel Releasing PTCA Balloon Catheter
- Model / Reference
- RP 2.25-30
- Primary DI / UDI-DI
- 05906190154149
- Basic UDI-DI
- B-05906190154149
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005316
Other devices from Cardionovum GmbH
Properties
Other properties (9)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No