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Paragon Infant PMP Oxygenator
EUDAMEDClass IIa (EU MDR)
Ref XCMOP145PMPModel Infant PMP
Identity
- Device Name
- Paragon Infant PMP Oxygenator EUDAMED
- Model / Reference
- Infant PMP EUDAMEDXCMOP145PMP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060491610213 EUDAMED
- Basic UDI-DI
- B-05060491610213 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 Infant 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-05060491610213 | 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 c74ab801-6f40-4ec2-bd2e-04c91df2df99 61 fields · synced Jun 19, 2026