Eu Mdd
Eu Md Class 2b
On The Market
๐บ๐ธ United States
HAEMOPERFUSION RESIN FILTERS
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 01230000006187
- Basic UDI-DI Code
- B-01230000006187
- Reference
- 30-0061
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- CytoSorbents Inc.
Additional Description
ECOS-300CY (ECOS) is a non-pyrogenic, sterile, single-use polymer-based adsorption system designed for the dialysis of ex vivo organ perfusion solutions in the area of extracorporeal therapies. ECOS is intended to be used with ex vivo organ perfusion systems (e.g. ex vivo normothermic/ hypothermic machine perfusion).
CND Nomenclature Codes
| Code | Description |
|---|---|
| F010702 | HAEMOPERFUSION RESIN FILTERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 3804606CE01 | DEKRA Certification B.V. | Expired |
Available In Countries
๐ฌ๐ท Greece
๐ฎ๐น Italy
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