Identity
- Trade Name
- CytoSorb 300 EUDAMED
- Device Name
- CytoSorb 300 mL Device EUDAMED
- Model / Reference
- 30-0031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 01230000006002 EUDAMED
- Basic UDI-DI
- B-01230000006002 EUDAMED
- EMDN Code
- F010702 HAEMOPERFUSION RESIN FILTERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CytoSorb 300 by CytoSorbents Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-01230000006002 | Class IIb | Active |
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Manufacturer
- Manufacturer
- CytoSorbents Inc.
- EUDAMED SRN
- US-MF-000002213
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED 982b488d-932b-4b93-88aa-3181e2d644b8 61 fields · synced Jun 18, 2026