Identity
- Device Name
- OCS Heart Console EUDAMED
- Model / Reference
- 100004929 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B009OCSHeartConsole2E EUDAMED
- Basic UDI-DI
- ++B009OCSHeartConsole2E EUDAMED
- Direct Marketing DI
- B00949290 EUDAMED
- EMDN Code
- Z12050201 EXTRA-CORPOREAL CIRCULATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania 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
OCS Heart Console by TransMedics, Inc — Class IIa — 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 | ++B009OCSHeartConsole2E | Class IIa | Active |
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Manufacturer
- Manufacturer
- TransMedics, Inc
- EUDAMED SRN
- US-MF-000029912
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 57616fbf-43a3-435f-8d42-bb5d2bc3165c 61 fields · synced Jun 19, 2026