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Membrane Oxygenator Adult BRCoating
EUDAMEDClass IIa (EU MDR)
Ref 622375Model Membrane Oxygenator Adult BRCoatingRef 617313Model Membrane Oxygenator Adult
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Membrane Oxygenator Adult BRCoating EUDAMEDMembrane Oxygenator Adult EUDAMED
- Device Name
- Membrane Oxygenator Adult BRCoating EUDAMEDMembrane Oxygenator Adult EUDAMED
- Model / Reference
- Membrane Oxygenator Adult BRCoating EUDAMED622375 EUDAMEDMembrane Oxygenator Adult EUDAMED617313 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350686 EUDAMED07898716350044 EUDAMED
- Basic UDI-DI
- 78987163562237574 EUDAMEDB-07898716350044 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 Adult BRCoating by Braile Biomédica Indústria Comércio e Representações Ltda. — Class IIa — MDR, MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 78987163562237574 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 78987163562237574 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (2)
- EUDAMED 4355ae0b-b034-423a-9527-f3d0079e15bc 61 fields · synced Jul 14, 2026
- EUDAMED 331700df-54fd-4862-9db4-e8e15e6aee26 61 fields · synced May 17, 2026