SRF618K9
Basic Information
- Primary DI
- 06934667966154
- Basic UDI-DI Code
- B-06934667966154
- Reference
- 069346679
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Guangzhou Sunray Medical Apparatus Co., Ltd.
Additional Description
The SRF618K9 Maternal and Fetal Monitor is intended for non-invasive monitoring of the physiological parameters of pregnant women during antepartum testing, labor and delivery. It’s intended for monitoring maternal ECG, maternal non-invasive blood pressure (NIBP), maternal oxygen saturation (SpO2), maternal respiration rate (Resp), maternal body temperature (Temp), Uterine Activity (UA), Fetal Movement (FM), and Fetal Heart Rate (FHR) of single fetuses, twins, and triplets. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. It is not intended for home use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1203020299 | MULTI–PARAMETER MONITORS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 048151 0005 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).