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Holder for Standalone Paragon Neonatal Oxygenator
EUDAMEDClass I (EU MDR)
Ref CMEH049Model Holder for Standalone Oxygenator
Identity
- Trade Name
- Holder for Standalone Paragon Neonatal Oxygenator EUDAMED
- Device Name
- Holder for Standalone Paragon Adult, Paediatric and Infant Oxygenator EUDAMED
- Model / Reference
- Holder for Standalone Oxygenator EUDAMEDCMEH049 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060912581764 EUDAMED
- Basic UDI-DI
- 50564696HoldersYR EUDAMED
- Direct Marketing DI
- 05060912581764 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Holder for Standalone Paragon Neonatal Oxygenator by Chalice Medical Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50564696HoldersYR | Class I | 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 (1)
- EUDAMED d689341d-ed6b-485a-bbe9-1ba887db7018 61 fields · synced Jun 19, 2026