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Membrane Oxygenator Newborn 800 / BRV 500 BRCoating
EUDAMEDClass IIa (EU MDR)
Ref 622381Model Membrane Oxygenator Newborn 800 / BRV 500 BRCoating
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Membrane Oxygenator Newborn 800 / BRV 500 BRCoating EUDAMED
- Device Name
- Membrane Oxygenator Newborn 800 / BRV 500 BRCoating EUDAMED
- Model / Reference
- Membrane Oxygenator Newborn 800 / BRV 500 BRCoating EUDAMED622381 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350747 EUDAMED
- Basic UDI-DI
- 7898716356223816X EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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 Newborn 800 / BRV 500 BRCoating 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 | 7898716356223816X | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (1)
- EUDAMED 1296c627-139a-47c2-b404-565f41a65bfc 61 fields · synced Jun 18, 2026