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OCS Lung Instrumentation Tool Set
EUDAMEDClass IIa (EU MDR)
Ref 2401, 2402, 2403, 2404
Identity
- Device Name
- OCS Lung Instrumentation Tool Set EUDAMED
- Model / Reference
- 2401, 2402, 2403, 2404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B009OCSLungAccessoryJF EUDAMED
- Basic UDI-DI
- ++B009OCSLungAccessoryJF EUDAMED
- Direct Marketing DI
- B009OCSLungAccessoryJF EUDAMED
- EMDN Code
- Z12050285 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 Lung Instrumentation Tool Set 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 | ++B009OCSLungAccessoryJF | 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 ba8a0581-6534-4268-bf1f-a383a6bcf0fd 61 fields · synced Jun 19, 2026
- EUDAMED ba8a0581-6534-4268-bf1f-a383a6bcf0fd-1 61 fields · synced Jun 11, 2026