Eu Mdd
Eu Md Class 2b
On The Market
π°π· South Korea
HF-525Plus
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- 08800123000015
- Basic UDI-DI Code
- B-08800123000015
- Reference
- None
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- ECORAY Co., Ltd
Additional Description
The HF-525Plus is intended for use diagnosing human beings and could get good regulations by controlled digital value by microprocessor, by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of body parts.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z110310 | MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 12966-2018-CE-KOR-NA-PS | DNV Product Assurance AS | Expired |
Available In Countries
π¦πΉ Austria
π¬π· Greece
πͺπΈ Spain
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