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OCS Heart Accessories
EUDAMEDClass IIa (EU MDR)
Ref 1424, 1400, 1421, 1425, 1404, 1406, 1457, 1411, 1408, 1401, 1426, 1423, 1427, 1410, 1461, 1460, 1466, 1467
Identity
- Device Name
- OCS Heart Accessories EUDAMED
- Model / Reference
- 1424, 1400, 1421, 1425, 1404, 1406, 1457, 1411, 1408, 1401, 1426, 1423, 1427, 1410, 1461, 1460, 1466, 1467 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B009OCSHeartAccessoryJT EUDAMED
- Basic UDI-DI
- ++B009OCSHeartAccessoryJT EUDAMED
- Direct Marketing DI
- B009OCSHeartAccessoryJT EUDAMED
- EMDN Code
- B010199,Z12050285 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
Yes
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
OCS Heart Accessories 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 | ++B009OCSHeartAccessoryJT | 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 (2)
- EUDAMED 90533f6a-fc63-4c73-8bf6-4d917e46d6e6 61 fields · synced Jun 18, 2026
- EUDAMED 90533f6a-fc63-4c73-8bf6-4d917e46d6e6-1 61 fields · synced Jun 10, 2026