Aster System
by Tema Sinergie S.p.A. Italy EUDAMED
Ref 135000074Model ASTER SYSTEM
EMDN Z12030301,Z12030380
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8056351100000ASTERSYSY9 | Date20 May 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Administration System for Theranostic
- Model / Reference
- ASTER SYSTEM, 135000074
- Primary DI / UDI-DI
- 08056351100151
- Basic UDI-DI
- 8056351100000ASTERSYSY9
- EMDN Code
- Z12030301,Z12030380
- Device Class
- Class IIb
- Medical Purpose
- ASTER SYSTEM (Administration System for Theranostics) is a system used for the infusion of radiopharmaceuticals in radiometabolic therapy.
Manufacturer details
- EUDAMED SRN
- IT-PR-000038767
Other devices from Tema Sinergie S.p.a.
Properties & raw data
Show properties, registry sources and raw records
Other properties (1)
- Sterile: No
Sources (1)
- EUDAMED 37e704d9-ba84-46ae-b348-93a37a37764c