Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 08800018423103
- Basic UDI-DI Code
- B-08800018423103
- Reference
- RMF-2000B
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- DRTECH Corporation
Additional Description
This device is Radiological imaging device through non invasive examination of human being’s breast. It is used for breast screening and diagnosis by breast compression using the Radiation. This unit is adapted for spot mammographic examination but not adapted breast biopsy.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11030202 | DIGITAL MAMMOGRAPHY SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2195-MED-2108401 | Szutest Uygunluk Değerlendirme A.Ş. | Expired |
Available In Countries
🇩🇪 Germany
🇫🇷 France
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