Eu Mdd
Eu Md Class 2a
On The Market
π¨π³ China
SRF618B5
Devices (same UDI-DI)
1
Certificates
1
Countries
4
Notified Bodies
1
Basic Information
- Primary DI
- 06934667961159
- Basic UDI-DI Code
- B-06934667961159
- 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 Sunray Fetal Monitor is intended for noninvasive monitoring of Uterine Activity (UA), Fetal Movement (FM), and Fetal Heart Rate (FHR) . It is intended for antepartum use by trained healthcare personnel and 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
πͺπΈ Spain
π΅π± Poland
πΈπͺ Sweden
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