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Cardiopulmonary Bypass Kit Infant BRCoating
EUDAMEDClass IIa (EU MDR)
Ref 622278Model Cardiopulmonary Bypass Kit Infant BRCoating
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Cardiopulmonary Bypass Kit Infant BRCoating EUDAMED
- Device Name
- Cardiopulmonary Bypass Kit Infant BRCoating EUDAMED
- Model / Reference
- Cardiopulmonary Bypass Kit Infant BRCoating EUDAMED622278 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350815 EUDAMED
- Basic UDI-DI
- 78987163562227875 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 BRCoating by Braile Biomédica Indústria Comércio e Representações Ltda. — Class IIa — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 78987163562227875 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (1)
- EUDAMED 3f96f3a8-d1d5-460d-87fa-92a692813b58 61 fields · synced Jun 20, 2026