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Tubing Set ECMO Infant
EUDAMEDClass IIa (EU MDR)
Ref 617328Model Tubing Set ECMO Infant
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Tubing Set ECMO Infant EUDAMED
- Device Name
- Tubing Set ECMO Infant EUDAMED
- Model / Reference
- Tubing Set ECMO Infant EUDAMED617328 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350174 EUDAMED
- Basic UDI-DI
- B-07898716350174 EUDAMED
- EMDN Code
- C03010301 CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Tubing Set ECMO Infant by Braile Biomédica Indústria Comércio e Representações Ltda. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07898716350174 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (1)
- EUDAMED 4478397e-819b-4858-af5e-c1d4a08a4caa 61 fields · synced Jul 22, 2026