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Standard Infant ECC Tubing pack
EUDAMEDClass IIa (EU MDR)
Ref CME90033 - EModel Tubing PackRef CME90033Ref CME90033 - D
Identity
- Trade Name
- Standard Infant ECC Tubing pack EUDAMED
- Model / Reference
- Tubing Pack EUDAMEDCME90033 - E EUDAMEDCME90033 EUDAMEDCME90033 - D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912587742 EUDAMED05060912583508 EUDAMED05060912587384 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
- 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
Standard Infant 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 (3)
- EUDAMED 0344fd2f-a31c-4514-9eb8-1b0ca4eb7fcb 61 fields · synced Jul 30, 2026
- EUDAMED ace67eef-4b26-410a-8173-7fa31b44ee34 61 fields · synced May 17, 2026
- EUDAMED 00f60650-de0c-4fa3-9427-2d5d8dcdd56d 61 fields · synced May 18, 2026