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Pediatric VAD Tubing Pack (for use with PediVas)
EUDAMEDClass IIa (EU MDR)
Ref CME201-50061Model Cardiopulmonary Bypass System Priming Set
Identity
- Trade Name
- Pediatric VAD Tubing Pack (for use with PediVas) EUDAMED
- Model / Reference
- Cardiopulmonary Bypass System Priming Set EUDAMEDCME201-50061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912582266 EUDAMED
- Basic UDI-DI
- 50564696TPackCPBPTS EUDAMED
- EMDN Code
- C03010301 CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Pediatric VAD Tubing Pack (for use with PediVas) by Chalice Medical Ltd — 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 | 50564696TPackCPBPTS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chalice Medical Ltd
- EUDAMED SRN
- GB-MF-000010617
- Authorised Representative
- Chalice Medical Europe GmbH DE-AR-000007891
Sources (1)
- EUDAMED 52943953-d45d-40ec-9e40-44fd2d26c9ce 61 fields · synced Jun 19, 2026