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Paragon Adult Maxi Integrated Oxygenator
EUDAMEDClass IIa (EU MDR)
Ref XCMOPI300PPModel Maxi Integrated PP
Identity
- Trade Name
- Paragon Adult Maxi Integrated Oxygenator EUDAMED
- Device Name
- Paragon Adult Maxi Integrated Oxygenator EUDAMED
- Model / Reference
- Maxi Integrated PP EUDAMEDXCMOPI300PP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060491618790 EUDAMED05060912588749 EUDAMED
- Basic UDI-DI
- B-05060491618790 EUDAMEDB-05060912588749 EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMEDGermany 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-05060491618790 | 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 (2)
- EUDAMED 90b49052-8d44-4cf5-900a-956544518417 61 fields · synced Jul 11, 2026
- EUDAMED 4149637c-10a0-4d78-90e5-c928930e5ff4 61 fields · synced May 19, 2026