Eu Mdd
Eu Md Class 2a
On The Market
🇨🇳 China
HEPATIC FUNCTIONALITY EQUIPMENT
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- D-9100052XD
- Basic UDI-DI Code
- B-9100052XD
- Reference
- FT100
- Device Types
-
Single use
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Wuxi Hisky Medical Technologies Co., Ltd.
Additional Description
Shear Wave Quantificational Ultrasound Diagnostic System which is based on Transient Elastography technology, is intended to assess Liver fibrosis and steatosis
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12040103 | HEPATIC FUNCTIONALITY EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | No.G10873820002 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
🇭🇺 Hungary
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