Eu Mdd
Eu Md Class 2b
On The Market
๐ฐ๐ท South Korea
ULTRA 100
Devices (same UDI-DI)
1
Certificates
1
Countries
13
Notified Bodies
1
Basic Information
- Primary DI
- 08809661400028
- Basic UDI-DI Code
- B-08809661400028
- Reference
- EBF-U10-001
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- ECORAY Co., Ltd.
Additional Description
A diagnostic system to obtain the information necessary for the diagnosis of the patient through the anatomical structure of human body obtained by a film or an image processing (workstation) after process of examination using radiation exposure with cassette IP, CR or DR (Portable flat panel). (When using ULTRA 100 with the mobile support device, it is able to be used as a mobile x-ray equipment, but also it was intended and designed Portable X-ray to be carried easily and used in any place such as hospitals, clinics and etc in order to achieve X-ray images easily)
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11039016 | MOBILE RADIOGRAPHIC UNITS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 10114-2017-CE-KOR-NA-PS | DNV Product Assurance AS | Expired |
Available In Countries
๐ฆ๐น Austria
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ฌ๐ง United Kingdom
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