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Membrane Oxygenator Newborn 800 BRCoating
EUDAMEDClass IIa (EU MDR)
Ref 622271Model Membrane Oxygenator Newborn 800 BRCoatingRef 617317Model Membrane Oxygenator Newborn 800
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Membrane Oxygenator Newborn 800 BRCoating EUDAMEDMembrane Oxygenator Newborn 800 EUDAMED
- Device Name
- Membrane Oxygenator Newborn 800 BRCoating EUDAMEDMembrane Oxygenator Newborn 800 EUDAMED
- Model / Reference
- Membrane Oxygenator Newborn 800 BRCoating EUDAMED622271 EUDAMEDMembrane Oxygenator Newborn 800 EUDAMED617317 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350730 EUDAMED07898716350082 EUDAMED
- Basic UDI-DI
- 7898716356222716P EUDAMEDB-07898716350082 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 Newborn 800 BRCoating by Braile Biomédica Indústria Comércio e Representações Ltda. — Class IIa — MDD, MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7898716356222716P | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7898716356222716P | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (2)
- EUDAMED 21682798-2419-4d3d-ab22-b102d5d39252 61 fields · synced Jul 23, 2026
- EUDAMED d9713413-ddd2-45c0-9fdd-b42131cfe25e 61 fields · synced May 18, 2026