Eu Mdr
Eu Md Class 2b
On The Market
π¨π³ China
CT/PET SYSTEMS
Devices (same UDI-DI)
1
Certificates
0
Countries
3
Notified Bodies
0
Basic Information
- Primary DI
- 06971576832163
- Basic UDI-DI Code
- 697157683216ND
- Reference
- 88000922
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Shanghai United Imaging Healthcare Co.,Ltd.
Additional Description
The system is designed for providing anatomical and functional images. The PET provides the distribution of specific radiopharmaceuticals. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. PET and CT scans can be performed separately. The system is intended for assessing metabolic (molecular) and physiologic functions in various parts of the body, including the whole body, brain, head and neck, heart, lung, breast, gastrointestinal, urinary system and genital organ, musculoskeletal systems, and others organ or systems.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11020301 | CT/PET SYSTEMS |
Available In Countries
π«π· France
π³π± Netherlands
π΅π± Poland
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).
[TEST ENTRY]-1
Device
EU MDR
·
Eu Md Class 2b
·ResMed PTY LTD·On the market·1 country
HYOT 2700-20-2RD
Device
EU MDR
·
Eu Md Class 2b
·Hytech b.v.·On the market·32 countries
HiRise
Device
EU MDR
·
Eu Md Class 2b
·CurveBeam LLC·On the market·10 countries
InReach
Device
EU MDR
·
Eu Md Class 2b
·CurveBeam LLC·On the market·10 countries
Hemicolectomy left procedure pack
Device
EU MDR
·
Eu Md Class 2b
·On the market
Vivo 1
Device
EU MDR
·
Eu Md Class 2b
·Breas Medical AB·On the market·19 countries