Identity
- Device Name
- Stationary driving unit Ikus Rev. 2.1 EUDAMED
- Model / Reference
- D03I-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260090040652 EUDAMED
- Basic UDI-DI
- 4260090042496R9 EUDAMED
- Direct Marketing DI
- 04260090040652 EUDAMED
- EMDN Code
- Z12050201 EXTRA-CORPOREAL CIRCULATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Stationary driving unit Ikus Rev. 2.1 by Berlin Heart GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4260090042496R9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Berlin Heart GmbH
- EUDAMED SRN
- DE-MF-000006521
Sources (1)
- EUDAMED 23d6e10d-a9cb-46f3-9bf1-643e15ca10a7 61 fields · synced Jun 19, 2026