← Back to catalogue
Blood Reservoir Cardiotomy 4000 BRCoating
EUDAMEDClass IIa (EU MDR)
Ref 622272Model Blood Reservoir Cardiotomy 4000 BRCoatingRef 617333Model Blood Reservoir Cardiotomy 4000
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Blood Reservoir Cardiotomy 4000 BRCoating EUDAMEDBlood Reservoir Cardiotomy 4000 EUDAMED
- Device Name
- Blood Reservoir Cardiotomy 4000 BRCoating EUDAMEDBlood Reservoir Cardiotomy 4000 EUDAMED
- Model / Reference
- Blood Reservoir Cardiotomy 4000 BRCoating EUDAMED622272 EUDAMEDBlood Reservoir Cardiotomy 4000 EUDAMED617333 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350655 EUDAMED07898716350228 EUDAMED
- Basic UDI-DI
- 7898716356222726R EUDAMEDB-07898716350228 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
Blood Reservoir Cardiotomy 4000 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 | 7898716356222726R | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7898716356222726R | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (2)
- EUDAMED fce49b55-54e9-4e50-aea4-f45a805d4383 61 fields · synced Jul 17, 2026
- EUDAMED 770b2038-0071-4c10-818e-a8067344bb7e 61 fields · synced May 19, 2026