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Paragon Neonatal PMP Oxygenator
EUDAMEDClass IIa (EU MDR)
Ref XCMOP43PMPModel Neonatal PMP
Identity
- Device Name
- Paragon Neonatal PMP Oxygenator EUDAMED
- Model / Reference
- Neonatal PMP EUDAMEDXCMOP43PMP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060491610206 EUDAMED
- Basic UDI-DI
- B-05060491610206 EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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 Neonatal PMP Oxygenator 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-05060491610206 | 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 502abcb2-67ae-4b29-9437-91257eaa8010 61 fields · synced Jul 14, 2026