Eu Mdd
Eu Md Class 2b
On The Market
๐ฐ๐ท South Korea
ULTRA 200A
Devices (same UDI-DI)
1
Certificates
1
Countries
12
Notified Bodies
1
Basic Information
- Primary DI
- 08809661400011
- Basic UDI-DI Code
- B-08809661400011
- Reference
- EBF-U20-001
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- ECORAY Co., Ltd.
Additional Description
The intended use of ULTRA 200A is to generate X-ray radiation to obtain X-ray images for the purpose of diagnosis of patients. ULTRA 200A is designed with wheels and movable to patients who are not able to visit a RAD Room, and useful in ER (Emergency Room) area.
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
๐ธ๐ฎ Slovenia
๐ฌ๐ง United Kingdom
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