← Back to catalogue
Paragon Adult Midi Integrated Oxygenator
EUDAMEDClass IIa (EU MDR)
Ref XCMOPI260PPModel Adult Midi Integrated
Identity
- Trade Name
- Paragon Adult Midi Integrated Oxygenator EUDAMED
- Device Name
- Paragon Adult Midi Integrated Oxygenator EUDAMED
- Model / Reference
- XCMOPI260PP EUDAMEDAdult Midi Integrated EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912588770 EUDAMED05060912588442 EUDAMED05060491617533 EUDAMED
- Basic UDI-DI
- B-05060912588770 EUDAMEDB-05060912588442 EUDAMEDB-05060491617533 EUDAMED
- EMDN Code
- C03010102 OXYGENATOR KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDCzechia EUDAMEDTürkiye 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 Midi 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-05060912588770 | 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 (3)
- EUDAMED 5b9d284e-f6f6-4bfd-8b0a-7d8322e5603e 61 fields · synced Jul 31, 2026
- EUDAMED f83af5d9-8831-466b-9ba6-895a4ef7df38 61 fields · synced May 19, 2026
- EUDAMED 3ff95b02-ea8a-49ba-8b11-7010cc8b57fa 61 fields · synced May 19, 2026