← Back to catalogue
Paragon Infant Micronet Integrated Oxygenator
EUDAMEDClass IIa (EU MDR)
Ref XCMOPI140MNModel Infant Micronet
Identity
- Trade Name
- Paragon Infant Micronet Integrated Oxygenator EUDAMED
- Device Name
- Paragon Infant MicroNet Integrated Oxygenator EUDAMED
- Model / Reference
- Infant Micronet EUDAMEDXCMOPI140MN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912586738 EUDAMED
- Basic UDI-DI
- B-05060912586738 EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Micronet 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-05060912586738 | 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
- Chalice Medical Europe GmbH DE-AR-000007891
Sources (1)
- EUDAMED 81fed891-76bf-47e8-8bdb-8e5af31ae705 61 fields · synced Jun 19, 2026