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Coated Lineas CEC Tubing Pack
EUDAMEDClass IIa (EU MDR)
Ref XCME54003Model Bypass Coated Tubing Pack
Identity
- Trade Name
- Coated Lineas CEC Tubing Pack EUDAMED
- Model / Reference
- Bypass Coated Tubing Pack EUDAMEDXCME54003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912587957 EUDAMED
- Basic UDI-DI
- 50564696TPackctQ6 EUDAMED
- EMDN Code
- C03010301 CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Coated Lineas CEC Tubing Pack 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 | 50564696TPackctQ6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chalice Medical Ltd
- EUDAMED SRN
- GB-MF-000010617
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED d330b69e-5d6e-4031-a760-6caf957c9450 61 fields · synced Jun 18, 2026