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Paragon Adult Maxi Integrated Oxygenator with Micronet Filter
EUDAMEDClass IIa (EU MDR)
Ref XCMOPI300MNModel Maxi Micronet
Identity
- Trade Name
- Paragon Adult Maxi Integrated Oxygenator with Micronet Filter EUDAMED
- Device Name
- Paragon Adult Maxi Integrated Oxygenator with Micronet Filter EUDAMED
- Model / Reference
- Maxi Micronet EUDAMEDXCMOPI300MN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912586653 EUDAMED
- Basic UDI-DI
- B-05060912586653 EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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 Adult Maxi 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-05060912586653 | 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 7a8bac53-e64d-47f1-a708-90935bcd2a4a 61 fields · synced Jun 18, 2026