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Cardiopulmonary Bypass Kit Infant 1500 BRCoating
EUDAMEDClass IIa (EU MDR)
Ref 622280Model Cardiopulmonary Bypass Kit Infant 1500 BRCoatingRef 617310Model Cardiopulmonary Bypass Kit Infant 1500
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Cardiopulmonary Bypass Kit Infant 1500 BRCoating EUDAMEDCardiopulmonary Bypass Kit Infant 1500 EUDAMED
- Device Name
- Cardiopulmonary Bypass Kit Infant 1500 BRCoating EUDAMEDCardiopulmonary Bypass Kit Infant 1500 EUDAMED
- Model / Reference
- Cardiopulmonary Bypass Kit Infant 1500 BRCoating EUDAMED622280 EUDAMEDCardiopulmonary Bypass Kit Infant 1500 EUDAMED617310 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350822 EUDAMED07898716350273 EUDAMED
- Basic UDI-DI
- 7898716356222806Q EUDAMEDB-07898716350273 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
Cardiopulmonary Bypass Kit Infant 1500 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 | 7898716356222806Q | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 7898716356222806Q | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (2)
- EUDAMED 11511c38-f508-4eac-b6fa-0f4645afa2c7 61 fields · synced Jul 16, 2026
- EUDAMED 6682df51-44d9-4e44-8c53-a1c1bd2d49c6 61 fields · synced May 17, 2026