← Back to catalogue
Cardiopulmonary Bypass Kit Newborn BRCoating
EUDAMEDClass IIa (EU MDR)
Ref 622284Model Cardiopulmonary Bypass Kit Newborn BRCoatingRef 617312Model Cardiopulmonary Bypass Kit Newborn
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Cardiopulmonary Bypass Kit Newborn BRCoating EUDAMEDCardiopulmonary Bypass Kit Newborn EUDAMED
- Device Name
- Cardiopulmonary Bypass Kit Newborn BRCoating EUDAMEDCardiopulmonary Bypass Kit Newborn EUDAMED
- Model / Reference
- Cardiopulmonary Bypass Kit Newborn BRCoating EUDAMED622284 EUDAMEDCardiopulmonary Bypass Kit Newborn EUDAMED617312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350846 EUDAMED07898716350297 EUDAMED
- Basic UDI-DI
- 7898716356222846Y EUDAMEDB-07898716350297 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 Newborn 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 | 7898716356222846Y | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7898716356222846Y | 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 c1912f6f-3f56-42be-86a1-0094b1d8d98e 61 fields · synced Jun 20, 2026
- EUDAMED e72c0696-ba6b-4e3d-868d-2de11fee3ff5 61 fields · synced May 17, 2026