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Paragon Paediatric Integrated Oxygenator with MicroNet Filter
EUDAMEDClass IIa (EU MDR)
Ref XCMOPI160MNModel Paediatric Integrated MN
Identity
- Device Name
- Paragon Paediatric Integrated Oxygenator with MicroNet Filter EUDAMED
- Model / Reference
- Paediatric Integrated MN EUDAMEDXCMOPI160MN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060491610244 EUDAMED
- Basic UDI-DI
- B-05060491610244 EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Paragon Paediatric Integrated Oxygenator with MicroNet Filter by Chalice Medical Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060491610244 | 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 (1)
- EUDAMED eb41030e-30f3-4b70-9b1f-a7d312cf7215 61 fields · synced Jul 19, 2026