Eu Mdd
Eu Md Class 2b
On The Market
🇨🇳 China
Digital Mammography System
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- D-06970021438196LX
- Basic UDI-DI Code
- B-06970021438196LX
- Reference
- 06970021438196
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- HEDY Medical Device Co.,Ltd.
Additional Description
The Digital Mammography System generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The Digital Mammography System is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists. This product is intended to be used in medical institutions or laboratories with X-ray radiation protection environment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11030202 | DIGITAL MAMMOGRAPHY SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | GCQ0933540002 Rev.00 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
🇨🇾 Cyprus
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