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Adult ECLS/ECMO Tubing Pack - Coated
EUDAMEDClass IIa (EU MDR)
Ref XCME14011Model ECMO Coated Tubing Pack inc OxygenatorRef XCME26002
Identity
- Trade Name
- Adult ECLS/ECMO Tubing Pack - Coated EUDAMEDCoated Adult ECMO Tubing Pack EUDAMED
- Device Name
- ECMO Coated Tubing Pack inc Oxygenator EUDAMED
- Model / Reference
- ECMO Coated Tubing Pack inc Oxygenator EUDAMEDXCME14011 EUDAMEDXCME26002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912587889 EUDAMED05060912587858 EUDAMED
- Basic UDI-DI
- 50564696TPackECctox7B EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMEDSlovenia 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
Adult ECLS/ECMO Tubing Pack - Coated 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 | 50564696TPackECctox7B | 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 (2)
- EUDAMED 7f00879d-b103-433f-8b5a-be7d67982f69 61 fields · synced Sep 18, 2026
- EUDAMED 0f54b4f1-c6ef-47c8-b31a-a35025c0fdd5 61 fields · synced Sep 18, 2026