Identity
- Device Name
- EXCOR Active driving unit EUDAMED
- Model / Reference
- 1502200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260090041840 EUDAMED
- Basic UDI-DI
- 4260090042540QK EUDAMED
- Direct Marketing DI
- 04260090041840 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
EXCOR Active driving unit 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 Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4260090042540QK | Class IIb | Unknown |
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Manufacturer
- Manufacturer
- Berlin Heart GmbH
- EUDAMED SRN
- DE-MF-000006521
Sources (1)
- EUDAMED 98b77169-d4a0-48c4-bd4f-0d2ddf580e01 61 fields · synced Jun 18, 2026