Eu Mdd
Eu Md Class 2a
On The Market
π¨π³ China
SRF618B6
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- 06934667961357
- Basic UDI-DI Code
- B-06934667961357
- Reference
- 069346679
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Guangzhou Sunray Medical Apparatus Co., Ltd.
Additional Description
The SRF618B6 Fetal Monitor is intended for non-invasive monitoring of the Fetal Heart Rate (FHR) of single fetuses, twins (optional) or triplets (optional), Uterine Activity (UA), and Fetal Movement (FM). It is intended for antepartum use by trained healthcare personnel. It is not intended for home use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12080101 | FOETAL MONITORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 048151 0005 | TΓV SΓD Product Service GmbH | Expired |
Available In Countries
π©πͺ Germany
π«π· France
π΅π± Poland
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