Organization name

Tema Sinergie S.p.a.

SRN

IT-MF-000027196

Manufacturer status

Active

Primary placement in Italy; available across 32 countries total.

Trade name

RAD-INJECT β

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08056351100021

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-08056351100021

Reference / catalog number

351010009

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

RAD-INJECT is designed and built to automatically inject doses of FDG, in order to minimize the dose absorbed by operators. The injection phase, given the method of administration of the radiopharmaceutical, subjects the doctor to exposure to radioactive substances, the infuser is a device that reduces the exposure time through the automation of the injection and in general by adopting the appropriate shielding it protects the operators involved more. Depending on radiopharmaceutical radiogenic emissions, the RADINJECT is available in the following versions: • RAD-INJECT BETA recommended for beta-emitting radiopharmaceuticals. • RAD-INJECT GAMMA recommended for gamma-emitting radiopharmaceuticals.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12030302SYRINGE PUMPS

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.