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Paragon Adult Maxi Integrated Oxygenator
EUDAMEDClass IIa (EU MDR)
Ref XCMOPI300MN
Identity
- Trade Name
- Paragon Adult Maxi Integrated Oxygenator EUDAMED
- Device Name
- Paragon Adult Maxi Integrated Oxygenator EUDAMED
- Model / Reference
- XCMOPI300MN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912588459 EUDAMED
- Basic UDI-DI
- B-05060912588459 EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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 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-05060912588459 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chalice Medical Ltd
- EUDAMED SRN
- GB-MF-000010617
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED de044a9e-196a-479c-89d1-dd668c04f3b2 61 fields · synced Jun 19, 2026