Organization name

Tema Sinergie S.p.a.

SRN

IT-MF-000027196

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Caution

  USE THE RAD-INJECT β STAND STAND EXCLUSIVELY WITH THE PROVIDED TUNGSTEN SHIELDING AND THE PORTABLE INFUSOR RAD-INJECT β

Primary placement in Italy; available across 32 countries total.

Trade name

RAD-INJECT β STAND

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.

08056351100045

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.

80563511000000STRADB2C

Reference / catalog number

351010004

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 I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Stand for portable β-emitting radiopharmaceutical infuser

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.

• Z12030380INFUSION INSTRUMENTS - HARDWARE ACCESSORIES

• Class I medical devices in EUDAMED

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