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Tubing Set ECMO Adult
EUDAMEDClass IIa (EU MDR)
Ref 617327Model Tubing Set ECMO Adult
by Braile Biomédica Indústria Comércio e Representações Ltda.
Identity
- Trade Name
- Tubing Set ECMO Adult EUDAMED
- Device Name
- Tubing Set ECMO Adult EUDAMED
- Model / Reference
- Tubing Set ECMO Adult EUDAMED617327 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898716350167 EUDAMED
- Basic UDI-DI
- 78987163510159039001J4 EUDAMED
- EMDN Code
- C03010301 CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Tubing Set ECMO Adult by Braile Biomédica Indústria Comércio e Representações Ltda. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 78987163510159039001J4 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000016583
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (1)
- EUDAMED bb5383dd-b742-4957-b648-65e83fff9499 61 fields · synced Jun 18, 2026