Eu Mdd
Eu Md Class 2b
On The Market
๐ฐ๐ท South Korea
ULTRA 1040HF
Devices (same UDI-DI)
1
Certificates
1
Countries
13
Notified Bodies
1
Basic Information
- Primary DI
- 08809661400035
- Basic UDI-DI Code
- B-08809661400035
- Reference
- EUM-01
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- ECORAY Co., Ltd.
Additional Description
ULTRA 1040HF is a x-ray device for diagnosing fracture conditions in whole body [excluding abdomen(Lateral)] of pediatric patient(from the age of 6) and adult patient and is for primary diagnosis of fracture conditions for elderly or unmovable patients or emergency patients. To use this equipment to acquire images, it must be fixed on a stationary stand before use
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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