Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- D-06970021438158LP
- Basic UDI-DI Code
- B-06970021438158LP
- Reference
- 06970021438158
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- HEDY Medical Device Co.,Ltd.
Additional Description
The Syringe Pump is intended to be used for the controlled administration of fluids. The Syringe Pump is intended for the intravenous injection. The Syringe Pump is intended to be used in conjunction with legally marketed and compatible syringes. The Syringe Pump is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas. And it is not suitable for environments of ambulance and other transportation. The Syringe Pump is intended for use on adults, pediatrics and neonates. The Syringe Pump is intended to be used by trained healthcare professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030302 | SYRINGE PUMPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | GCQ0933540002 Rev.00 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
🇵🇱 Poland
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).
Horizontal Steam Sterilizer
Device
EU MDD
·
Eu Md Class 2b
·PROHS Equipamento Hospitalar e Serviços Associados S.A.·On the market·10 countries
Adacolumn
Device
EU MDD
·
Eu Md Class 2b
·JIMRO Co., Ltd.·On the market·9 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·8 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·7 countries
Sonovein
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·6 countries
Mevion S250i
Device
EU MDD
·
Eu Md Class 2b
·Mevion Medical Systems, Inc.·On the market·1 country