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Standard Adult ECC Tubing Pack
EUDAMEDClass IIa (EU MDR)
Ref CME90034Model Tubing Pack
Identity
- Trade Name
- Standard Adult ECC Tubing Pack EUDAMED
- Model / Reference
- Tubing Pack EUDAMEDCME90034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912587094 EUDAMED05060912583515 EUDAMED
- Basic UDI-DI
- 50564696TPack2L EUDAMED
- EMDN Code
- C03010301 CARDIOPULMONARY SUPPORT KITS (C.P.S. AND ECMO) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDGermany 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
Standard Adult ECC 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 | 50564696TPack2L | 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 (2)
- EUDAMED 3deab8cb-218a-42d4-bd85-73189c09bc1a 61 fields · synced Sep 17, 2026
- EUDAMED edc47a39-0432-4590-91b6-06a994ed89c4 61 fields · synced May 19, 2026