Basic UDI-DI
Eu Mdr
Eu Md Class 2b
KARL 100 2.0 SYSTEM
Code: 8056351100000KARL2.0SYSPL
Devices
1
Certificates
0
Notified Bodies
0
Auth. Representatives
0
Basic Information
- UDI-DI Code
- 8056351100000KARL2.0SYSPL
- Issuing Agency
- GS1
- Device Model
- Portable Automatic Dose Dispensing System
- Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2b
- Last Updated
- July 23, 2024
Medical Purpose
The transportable automatic fractionation system (Karl 100 2.0 System) is a medical system for the safe storage and protection of operators of the FDG radiopharmaceutical ([18F]-fluorodeoxyglucose) and, associated with a dose calibrator, manages the measurement of the fractionation by placing the radiopharmaceutical with the necessary level of activity in a syringe.
Certificate Health
No certificates associated with this Basic UDI-DI.
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| KARL 100 2.0 SYSTEM | On the market |