Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06261786700018
- Basic UDI-DI Code
- B-06261786700018
- Reference
- WPM2
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- No Longer On The Market
- Manufacturer
- Ehya Darman Pishrafteh
Additional Description
The EDP-TS is microprocessor-controlled mechanical ventilators which incorporate the most advanced methods for ventilator support. The electronic circuit operates two proportional valves which provide the gas flow necessary to satisfy the selected configuration. Ventilator was designed to be used by adult patients who require invasive and noninvasive ventilatory support, for a short or long period and they allow to monitor the main ventilatory parameters. The equipment provide care for patients able or unable to make their own breathing efforts.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z1203010502 | ADULT PULMONARY VENTILATORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | EPT0477.MDD.20/3799 | Eurofins Product Testing Italy S.r.l. | Expired |
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