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ECMO Tubing Pack with Neonatal Paragon PMP Oxygenator
EUDAMEDClass IIa (EU MDR)
Ref CME90004Model ECMO Tubing Pack including Oxygenator
Identity
- Trade Name
- ECMO Tubing Pack with Neonatal Paragon PMP Oxygenator EUDAMED
- Model / Reference
- ECMO Tubing Pack including Oxygenator EUDAMEDCME90004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912587803 EUDAMED
- Basic UDI-DI
- 50564696TpackECoxG9 EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS 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
ECMO Tubing Pack with Neonatal Paragon PMP Oxygenator 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 | 50564696TpackECoxG9 | 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 e0f19e0f-d94c-42ff-adc3-f51e05724dd0 61 fields · synced Jun 19, 2026