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Membrane Oxygenator Oxyprime ECMO Adult
EUDAMEDClass IIa (EU MDR)
Ref 617320Model Membrane Oxygenator Oxyprime ECMO AdultRef 617321Model Membrane Oxygenator Oxyprime ECMO Adult 5
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Membrane Oxygenator Oxyprime ECMO Adult EUDAMEDMembrane Oxygenator Oxyprime ECMO Adult 5 EUDAMED
- Device Name
- Membrane Oxygenator Oxyprime ECMO Adult EUDAMEDMembrane Oxygenator Oxyprime ECMO Adult 5 EUDAMED
- Model / Reference
- Membrane Oxygenator Oxyprime ECMO Adult EUDAMED617320 EUDAMEDMembrane Oxygenator Oxyprime ECMO Adult 5 EUDAMED617321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350020 EUDAMED07898716350037 EUDAMED
- Basic UDI-DI
- 78987163510159030111GD EUDAMEDB-07898716350037 EUDAMED
- EMDN Code
- C03010301 CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Membrane Oxygenator Oxyprime ECMO Adult by Braile Biomédica Indústria Comércio e Representações Ltda. — Class IIa — MDD, MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 78987163510159030111GD | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 78987163510159030111GD | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (2)
- EUDAMED 8c94fa20-cef1-459e-86ca-217eb84c628a 61 fields · synced Jul 13, 2026
- EUDAMED 1865756a-48d5-43fd-b350-45426a5e32c0 61 fields · synced May 18, 2026