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Membrane Oxygenator Adult / BRV 4000
EUDAMEDClass IIa (EU MDR)
Ref 617336Model Membrane Oxygenator Adult / BRV 4000Ref 622378Model Membrane Oxygenator Adult / BRV 4000 BRCoating
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Membrane Oxygenator Adult / BRV 4000 EUDAMEDMembrane Oxygenator Adult / BRV 4000 BRCoating EUDAMED
- Device Name
- Membrane Oxygenator Adult / BRV 4000 EUDAMEDMembrane Oxygenator Adult / BRV 4000 BRCoating EUDAMED
- Model / Reference
- Membrane Oxygenator Adult / BRV 4000 EUDAMED617336 EUDAMEDMembrane Oxygenator Adult / BRV 4000 BRCoating EUDAMED622378 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350099 EUDAMED07898716350693 EUDAMED
- Basic UDI-DI
- B-07898716350099 EUDAMED7898716356223787A EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDPortugal 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 / BRV 4000 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 | B-07898716350099 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07898716350099 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (2)
- EUDAMED 581cda98-2fa7-4bc7-8053-e64afc085b8c 61 fields · synced Jul 31, 2026
- EUDAMED e7d82e99-5ae2-414c-9ac7-2d34d67237c8 61 fields · synced May 17, 2026