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OCS Accessories/Components
EUDAMEDClass I (EU MDR)
Ref 1404, 1406, 1408, 1411, 1423, 1428, 1429, 1430, 1431, 1432, 1434, 1436, 2460, 2461, 2464, 1460
Identity
- Device Name
- OCS Accessories/Components EUDAMED
- Model / Reference
- 1404, 1406, 1408, 1411, 1423, 1428, 1429, 1430, 1431, 1432, 1434, 1436, 2460, 2461, 2464, 1460 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B009OCSCommon2L EUDAMED
- Basic UDI-DI
- ++B009OCSCommon2L EUDAMED
- EMDN Code
- V0903,V80,Z12050280 EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OCS Accessories/Components by TransMedics, Inc — Class I — 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 | ++B009OCSCommon2L | Class I | 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 5cf56ac0-6bf3-4552-9739-e9307dfd6a7d 61 fields · synced Jul 31, 2026
- EUDAMED 5cf56ac0-6bf3-4552-9739-e9307dfd6a7d-1 61 fields · synced Jun 10, 2026