Rad-Inject Β

by Tema Sinergie S.p.a. Italy EUDAMED

Ref 351010009Model RADIOPHARMACEUTICAL PORTABLE INFUSER

EMDN Z12030302

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-08056351100021 Basic UDI-DI	Date25 Jul 2024Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: RADIOPHARMACEUTICAL PORTABLE INFUSER, 351010009

Primary DI / UDI-DI: 08056351100021
Basic UDI-DI: B-08056351100021
EMDN Code: Z12030302 Syringe pumps

Device Class: Class IIb
Market of Registration: Italy

Manufacturer details

EUDAMED SRN: IT-MF-000027196

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Properties & raw data

Show properties, registry sources and raw records

Other properties (11)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No

Sources (1)

EUDAMED c212bfed-5917-456a-819c-b02741b7e2ad 61 fields · synced 22 Oct 2026