Identity
- Device Name
- OCS Class IIa Accessories/Components EUDAMED
- Model / Reference
- 100004460 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B009OCSCommonClass2aGF EUDAMED
- Basic UDI-DI
- ++B009OCSCommonClass2aGF EUDAMED
- Direct Marketing DI
- B00944603 EUDAMED
- EMDN Code
- Z12050285 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - CONSUMABLES 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 Class IIa Accessories/Components 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 | ++B009OCSCommonClass2aGF | 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 f239825f-4434-4e7e-bc5f-aac14d4f0710 61 fields · synced Jun 18, 2026