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Membrane Oxygenator Newborn 800 / BRV 500
EUDAMEDClass IIa (EU MDR)
Ref 617337Model Membrane Oxygenator Newborn 800 / BRV 500
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Membrane Oxygenator Newborn 800 / BRV 500 EUDAMED
- Device Name
- Membrane Oxygenator Newborn 800 / BRV 500 EUDAMED
- Model / Reference
- Membrane Oxygenator Newborn 800 / BRV 500 EUDAMED617337 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350105 EUDAMED
- Basic UDI-DI
- B-07898716350105 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 Newborn 800 / BRV 500 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-07898716350105 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (1)
- EUDAMED 52174833-08d3-4058-9d37-52b3712397f2 61 fields · synced Jun 18, 2026