← Back to catalogue
Paragon Adult Maxi Integrated Oxygenator with MicroNet Filter
EUDAMEDClass IIa (EU MDR)
Ref XCMOPI300MNModel Paragon Integrated Oxygenator
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
- XCMOPI300MN EUDAMEDParagon Integrated Oxygenator EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912588763 EUDAMED05060491610350 EUDAMED
- Basic UDI-DI
- B-05060912588763 EUDAMEDB-05060491610350 EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDAustria 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-05060912588763 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chalice Medical Ltd
- EUDAMED SRN
- GB-MF-000010617
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 8e52b3c9-b0fe-48f3-ba3b-b30b4a152265 61 fields · synced Jul 23, 2026
- EUDAMED 17bba561-d691-4f1d-bdb8-33adb05dbcad 61 fields · synced May 19, 2026