Eu Mdd
Eu Md Class 2b
No Longer On The Market
🇨🇳 China
DIGITAL MAMMOGRAPHY SYSTEMS
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06950743803038
- Basic UDI-DI Code
- B-06950743803038
- Reference
- ASR-4000
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- No Longer On The Market
- Manufacturer
- Shenzhen Anke High-tech Co., Ltd.
Additional Description
The system is mainly made up of the main frame, console, PDU, the image workstation, wherein the main frame is composed of the body and head, specifically including: C arm, X-ray tube holder, X-ray tube, Collimator, Compressor, the flat detector, body keys, head keys etc. the image workstation of system doesn’t belong to the medical equipment but general equipment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11030202 | DIGITAL MAMMOGRAPHY SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 043041 0022 | TÜV SÜD Product Service GmbH | Expired |
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