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Membrane Oxygenator Oxyprime 7000
EUDAMEDClass IIa (EU MDR)
Ref 617318Model Membrane Oxygenator Oxyprime 7000
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Membrane Oxygenator Oxyprime 7000 EUDAMED
- Device Name
- Membrane Oxygenator Oxyprime 7000 EUDAMED
- Model / Reference
- Membrane Oxygenator Oxyprime 7000 EUDAMED617318 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350006 EUDAMED
- Basic UDI-DI
- B-07898716350006 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Membrane Oxygenator Oxyprime 7000 by Braile Biomédica Indústria Comércio e Representações Ltda. — Class IIa — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07898716350006 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (1)
- EUDAMED 3711187c-e9c8-4901-a0a0-e0210424c85d 61 fields · synced Jul 26, 2026