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Tubing Set ECMO Newborn
EUDAMEDClass IIa (EU MDR)
Ref 617329Model Tubing Set ECMO Newborn
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Tubing Set ECMO Newborn EUDAMED
- Device Name
- Tubing Set ECMO Newborn EUDAMED
- Model / Reference
- Tubing Set ECMO Newborn EUDAMED617329 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350181 EUDAMED
- Basic UDI-DI
- B-07898716350181 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 Newborn 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-07898716350181 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (1)
- EUDAMED 031583f9-f451-4d04-b039-31baf86c7ce0 61 fields · synced Jun 19, 2026