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OCS Liver Accessories
EUDAMEDClass IIa (EU MDR)
Ref 3400, 3401, 3421, 3457, 3450, 1467, 3406, 1404, 1408, 1411, 1423, 1428, 1429, 1430, 1431, 1432, 1434, 1436, 1460
Identity
- Device Name
- OCS Liver Accessories EUDAMED
- Model / Reference
- 3400, 3401, 3421, 3457, 3450, 1467, 3406, 1404, 1408, 1411, 1423, 1428, 1429, 1430, 1431, 1432, 1434, 1436, 1460 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B009OCSLiverAccessory7A EUDAMED
- Basic UDI-DI
- ++B009OCSLiverAccessory7A EUDAMED
- Direct Marketing DI
- B009OCSLiverAccessory7A EUDAMED
- EMDN Code
- V0903,V80,Z12050280,Z12050285 EUDAMED
Classification
- Device Class
- Class IIa 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 Liver 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 | ++B009OCSLiverAccessory7A | 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 f4126bea-7834-4765-bd59-a7b4a492aeea 61 fields · synced Jul 9, 2026
- EUDAMED f4126bea-7834-4765-bd59-a7b4a492aeea-1 61 fields · synced Jun 9, 2026