← Back to catalogue
Membrane Oxygenator Oxyprime Duo
EUDAMEDClass IIa (EU MDR)
Ref 618949Model Membrane Oxygenator Oxyprime Duo
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Membrane Oxygenator Oxyprime Duo EUDAMED
- Device Name
- Membrane Oxygenator Oxyprime Duo EUDAMED
- Model / Reference
- Membrane Oxygenator Oxyprime Duo EUDAMED618949 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350594 EUDAMED
- Basic UDI-DI
- 78987163510159039004JA EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS 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 Duo by Braile Biomédica Indústria Comércio e Representações Ltda. — Class IIa — MDR — listed in EUDAMED
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 | 78987163510159039004JA | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (1)
- EUDAMED 3392ed26-8eb8-4199-a519-ed4068be15b0 61 fields · synced Jun 18, 2026