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Cardiopulmonary Bypass Kit Pediatric BRCoating

EUDAMED

Class IIa (EU MDR)

Ref 622282Model Cardiopulmonary Bypass Kit Pediatric BRCoating

by Braile Biomédica Indústria Comércio e Representações Ltda.

Identity

Trade Name
Cardiopulmonary Bypass Kit Pediatric BRCoating EUDAMED
Device Name
Cardiopulmonary Bypass Kit Pediatric BRCoating EUDAMED
Model / Reference
Cardiopulmonary Bypass Kit Pediatric BRCoating EUDAMED
622282 EUDAMED

Identifiers

Primary DI / UDI-DI
07898716350839 EUDAMED
Basic UDI-DI
7898716356222826U 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 Pediatric 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

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Manufacturer

EUDAMED SRN
BR-MF-000016583
Authorised Representative
Mars Medical DE-AR-000006312

Sources (1)

  • EUDAMED 7719b356-3082-446e-b6ca-f68a94739837 61 fields · synced Sep 18, 2026