Basic Information
- Primary DI
- 08056351100021
- Basic UDI-DI Code
- B-08056351100021
- Reference
- 351010009
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Tema Sinergie S.p.a.
Additional 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030302 | SYRINGE PUMPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | MED 25033 | KIWA CERMET ITALIA S.P.A. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).