Eu Mdr
Eu Md Class 2b
On The Market
๐บ๐ธ United States
HiRise
Devices (same UDI-DI)
2
Certificates
0
Countries
10
Notified Bodies
0
Basic Information
- Primary DI
- 00860004550037
- Basic UDI-DI Code
- 8631520003CBCTDevicesCL
- Reference
- 1040
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- CurveBeam LLC
Additional Description
The HiRise is intended to be used for 3-D imaging of the upper and the lower extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs. The device is to be operated in a professional healthcare environment by qualified health care professionals only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11030699 | COMPUTED TOMOGRAPHS (CT) - OTHER |
Available In Countries
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ท๐ด Romania
Related Devices
The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.
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
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
Vivo 2
Device
EU MDR
·
Eu Md Class 2b
·Breas Medical AB·On the market·21 countries
CHILI PACS
Device
EU MDR
·
Eu Md Class 2b
·NEXUS / CHILI GmbH·On the market·3 countries